Non-small Cell Lung Cancer (NSCLC)Phase 3AdvanTIG-306NCT05791097
Study of Efficacy and Safety of Ociperlimab in Combination With Tislelizumab and Platinum-based Doublet Chemotherapy as First-line Treatment for Participants With Locally Advanced or Metastatic NSCLC.
A Phase 3 study testing Ociperlimab, Tislelizumab and Pembrolizumab in people with Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals.
Trial summary
The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Ociperlimab, Tislelizumab and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2023to 26 Dec 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation, radiation or surgery) or metastatic (stage IV) NSCLC (according to AJCC: Cancer Staging Manual, 8th edition) participants with no previous systemic treatment for advanced disease.
- Known PD-L1 status determined, prior to study randomization
- At least one measurable lesion as defined by RECIST 1.1 according to local radiology assessment at screening.
- ECOG performance status ≤1.
Who cannot join
- Active autoimmune diseases requiring treatment with steroids or immunosuppressors in the past 2 years prior to randomization.
- History of severe hypersensitivity reaction or any contraindication to ociperlimab, tislelizumab, pembrolizumab (or any other monoclonal antibodies), platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs.
- Participants with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Participants with documented epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement assessed as part of the patients's standard of care by a validated test, as per local regulations will be excluded from the study.
- Participants with other known druggable molecular drivers (any histology) such as BRAF V600, KRASG12C, MET exon 14 mutations, NTRK, RET or ROS-1 rearrangement diagnosed per local tests who might be candidates for alternative targeted therapies as applicable per local regulations and treatment guidelines are excluded.
- Other inclusion/exclusion criteria may apply
About this study
Official title: AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.
Read the detailed description
This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy as first-line treatment for participants with locally advanced or metastatic NSCLC without actionable driver mutations.
Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Ociperlimab, Placebo, Tislelizumab, Pembrolizumab, Carboplatin
- Keywords
- AdvanTIG-306, ociperlimab, tislelizumab, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, squamous, non-squamous, non-small cell lung cancer, NSCLC, PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OciperlimabDrug
Also called WCD118
Ociperlimab is a monoclonal antibody formulated for intravenous infusion. 900 mg of ociperlimab will be administered on Day 1 of each 21-day cycle
PlaceboDrug
Placebo infusions will consist of a sterile, normal saline solution. Placebo will be administered on Day 1 of each 21-day cycle
TislelizumabDrug
Also called VDT482
Tislelizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of tislelizumab will be administered on Day 1 of each 21-day cycle
PembrolizumabDrug
Pembrolizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of pembrolizumab will be administered on Day 1 of each 21-day cycle
CarboplatinDrug
Carboplatin is a chemotherapy agent formulated for intravenous infusion. Carboplatin will be administered (AUC 6 mg/mL*min) on Day 1 of each 21-day cycle
CisplatinDrug
Cisplatin is a chemotherapy agent formulated for intravenous infusion. Cisplatin will be administered (75 mg/m^2) on Day 1 of each 21-day cycle
PemetrexedDrug
Pemetrexed is a chemotherapy agent formulated for intravenous infusion. Pemetrexed will be administered (500 mg/m^2) on Day 1 of each 21-day cycle
PaclitaxelDrug
Paclitaxel is a chemotherapy agent formulated for intravenous infusion. Paclitaxel will be administered (200 mg/m^2) on Day 1 of each 21-day cycle
Nab-paclitaxelDrug
Nab-paclitaxel is a chemotherapy agent formulated for intravenous infusion. Nab-paclitaxel will be administered (100 mg/m^2) on Day 1, 8 and 15 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ociperlimab + tislelizumab + chemotherapy | Experimental | Participants will receive ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm B: Placebo + pembrolizumab + chemotherapy | Active comparator | Participants will receive ociperlimab placebo in combination with pembrolizumab and platinum-based doublet chemotherapy Receives: Drug: Placebo; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
| Arm C: Placebo + tislelizumab + chemotherapy | Placebo comparator | Participants will receive ociperlimab placebo in combination with tislelizumab and platinum-based doublet chemotherapy Receives: Drug: Placebo; Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment as per RECIST 1.1 in participants with PD-L1 expression in ≥1% of tumor cells (Arm A and B)
Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B
Measured: Up to 30 months
Overall survival (OS) in participants with PD-L1 expression in ≥1% of tumor cells (Arm A and B)
Time from date of randomization/start of treatment to date of death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B
Measured: Up to 52 months
Secondary outcomes (26)
PFS based on BIRC assessment as per RECIST 1.1 in all participants regardless of PD-L1 status (Arm A and B)
Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in all participants in Arm A compared to Arm B
Measured: Up to 30 months
OS in all participants regardless of PD-L1 status (Arm A and B)
Time from date of randomization/start of treatment to date of death due to any cause in all participants in Arm A compared to Arm B.
Measured: Up to 52 months
Overall response rate (ORR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Percentage of participants with best overall response of complete response (CR) or partial response (PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B
Measured: Up to 30 months
Disease Control Rate (DCR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Percentage of participants with best overall response of CR, PR or stable disease (SD)based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B
Measured: Up to 30 months
Time to response (TTR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time from the date of randomization to the date of first documented response (CR or PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B
Measured: Up to 30 months
Duration of response (DOR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm B
Measured: Up to 30 months
ORR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Percentage of participants with best overall response of complete response (CR) or partial response (PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C
Measured: Up to 30 months
DCR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Percentage of participants with best overall response of CR, PR or stable disease (SD)based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C
Measured: Up to 30 months
TTR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time from the date of randomization to the date of first documented response (CR or PR) based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C
Measured: Up to 30 months
DOR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause based in BIRC assessment as per RECIST 1.1 in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C
Measured: Up to 30 months
PFS based on BIRC assessment as per RECIST 1.1 (Arm A and C)
Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in participants with PD-L1 expression ≥1% and in all participants randomized, for participants in Arm A compared to Arm C
Measured: Up to 30 months
Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of ociperlimab and tislelizumab
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. AUClast will be summarized using descriptive statistics.
Measured: Up to 30 months
PK parameter: Maximum concentration (Cmax) of ociperlimab and tislelizumab
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Cmax will be summarized using descriptive statistics.
Measured: Up to 30 months
PK parameter: Time to reach maximum concentration (Tmax) of ociperlimab and tislelizumab
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Tmax will be summarized using descriptive statistics.
Measured: Up to 30 months
PK parameter: Lowest serum concentration reached before the next dose is administered (Ctrough) of ociperlimab and tislelizumab
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. Ctrough will be summarized using descriptive statistics.
Measured: Up to 30 months
PK parameter: AUC calculated at the end of the dosing interval (AUCtau)of ociperlimab and tislelizumab
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of ociperlimab and tislelizumab. AUCtau will be summarized using descriptive statistics.
Measured: Up to 30 months
Immunogenicity: Anti-drug antibodies (ADA) prevalence at baseline of ociperlimab and tislelizumab
Prevalence of ADA (anti-ociperlimab, anti-tislelizumab) at baseline is defined as the percentage of participants who have an ADA positive result at baseline
Measured: Baseline
Immunogenicity: ADA incidence following treatment with ociperlimab and tislelizumab
Incidence of ADA (anti-ociperlimab, anti-tislelizumab) on treatment is defined as the percentage of participants who are treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
Measured: Up to 30 months
Time to definitive 10-point deterioration in physical and role functioning on the EORTC QLQ-C30 questionnaire
The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.
The time to definitive 10 point deterioration of physical functioning and role functioning is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.
Measured: Up to 30 months
Time to definitive 10-point deterioration in symptom scores for chest pain, cough and dyspnea on the EORTC QLQ-LC13 questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.
The time to first 10 point deterioration symptom scores of chest pain, cough and dyspnea is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.
Measured: Up to 30 months
Time to confirmed 10-point deterioration in physical and role functioning on the EORTC QLQ-C30 questionnaire
The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.
The time to confirmed 10-point deterioration of physical functioning and role functioning is defined as the time from the date of randomization to first onset of≥10 points deterioration from baseline and confirmed by a second consecutive ≥10 points deterioration from baseline, or one assessment followed by death from any cause before the next scheduled data collection.
Measured: Up to 30 months
Time to confirmed 10-point deterioration in symptom scores for chest pain, cough and dyspnea on the EORTC QLQ-LC13 questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporates one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores range from 0 to 100. A high score indicates a high level of symptoms.
The time to first 10 point deterioration symptom scores of chest pain, cough and dyspnea is defined as the time from the date of randomization to first onset of≥10 points deterioration from baseline and confirmed by a second consecutive ≥10 points deterioration from baseline, or one assessment followed by death from any cause before the next scheduled data collection.
Measured: Up to 30 months
Time to definitive 10-point deterioration in global health status/quality of life, shortness of breath and pain on the EORTC QLQ-C30 questionnaire
The EORTC QLQ-C30 is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/quality of life (QoL) scale. All of the domain scores range from 0 to 100. A high score for a functional scale indicates a high and healthy level of functioning but a high score for a symptom scale indicates a high level of symptoms.
The time to definitive 10-point deterioration in global health status/quality of life, shortness of breath and pain scores is defined as the time from the date of randomization to first onset of ≥10 points increase from baseline (worsening) of the corresponding scale score, with no later change below this threshold or death due to any cause.
Measured: Up to 30 months
Utility scores of the EQ-5D-5L
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
Measured: Up to 30 months
Progression-free survival deferred (PFS2)
Time from date of randomization to the first documented progression on next line therapy or death from any cause, whichever occurs first
Measured: Up to 30 months
Time to definitive deterioration of the ECOG performance status
Time to definitive deterioration of the ECOG PS by one category of the score. The ECOG PS is a measure of functional status. It ranges from 0 to 5, with 0 denoting perfect health and 5 death. A deterioration is considered definitive if no improvements in the ECOG PS status is observed at any subsequent time of measurement during the treatment period following the time point where the deterioration is observed.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start28 Jul 2023 (estimated)
- Primary completion24 Dec 2027 (estimated)
- Study completion26 Dec 2027 (estimated)
Why it stopped: Business decision, not driven by safety concerns; no new safety signals have been observed in the ociperlimab program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791097
- Sponsor's protocol ID
- CWCD118A12301
- Other IDs
- 2022-503098-12-00
- Acronym
- AdvanTIG-306
- Status last verified
- Jul 2023
- First submitted
- 17 Mar 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05791097
- Acronym / sponsor ID
- AdvanTIG-306 / CWCD118A12301
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- AdvanTIG-306, ociperlimab, tislelizumab, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision, not driven by safety concerns; no new safety signals have been observed in the ociperlimab program.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2023 (estimated)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.
Detailed description
This is a randomized, double-blind, placebo controlled, multicenter, phase III study evaluating the efficacy and safety of ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy as first-line treatment for participants with locally advanced or metastatic NSCLC without actionable driver mutations.
Participants will receive study treatment every three weeks and will continue to receive it until RECIST 1.1 disease progression as determined by Investigator and confirmed by BIRC, unacceptable toxicity that precludes further treatment, treatment is discontinued at the discretion of the Investigator or participant, participant withdrawal of consent, pregnancy, lost to follow-up, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ociperlimab + tislelizumab + chemotherapy | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxelParticipants will receive ociperlimab in combination with tislelizumab and platinum-based doublet chemotherapy |
| Arm B: Placebo + pembrolizumab + chemotherapy | Active comparator | Drug: Placebo, Drug: Pembrolizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxelParticipants will receive ociperlimab placebo in combination with pembrolizumab and platinum-based doublet chemotherapy |
| Arm C: Placebo + tislelizumab + chemotherapy | Placebo comparator | Drug: Placebo, Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Nab-paclitaxelParticipants will receive ociperlimab placebo in combination with tislelizumab and platinum-based doublet chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation, radiation or surgery) or metastatic (stage IV) NSCLC (according to AJCC: Cancer Staging Manual, 8th edition) participants with no previous systemic treatment for advanced disease.
- Known PD-L1 status determined, prior to study randomization
- At least one measurable lesion as defined by RECIST 1.1 according to local radiology assessment at screening.
- ECOG performance status ≤1.
Key exclusion criteria (6 listed)
- Active autoimmune diseases requiring treatment with steroids or immunosuppressors in the past 2 years prior to randomization.
- History of severe hypersensitivity reaction or any contraindication to ociperlimab, tislelizumab, pembrolizumab (or any other monoclonal antibodies), platinum containing drugs, nab-paclitaxel, paclitaxel, pemetrexed or any known excipients of these drugs.
- Participants with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Participants with documented epidermal growth factor receptor (EGFR) sensitizing mutations, and/or ALK rearrangement assessed as part of the patients's standard of care by a validated test, as per local regulations will be excluded from the study.
- Participants with other known druggable molecular drivers (any histology) such as BRAF V600, KRASG12C, MET exon 14 mutations, NTRK, RET or ROS-1 rearrangement diagnosed per local tests who might be candidates for alternative targeted therapies as applicable per local regulations and treatment guidelines are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OciperlimabAlso: WCD118Ociperlimab is a monoclonal antibody formulated for intravenous infusion. 900 mg of ociperlimab will be administered on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy |
| PlaceboPlacebo infusions will consist of a sterile, normal saline solution. Placebo will be administered on Day 1 of each 21-day cycle | Drug | Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| TislelizumabAlso: VDT482Tislelizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of tislelizumab will be administered on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| PembrolizumabPembrolizumab is a monoclonal antibody formulated for intravenous infusion. 200 mg of pembrolizumab will be administered on Day 1 of each 21-day cycle | Drug | Arm B: Placebo + pembrolizumab + chemotherapy |
| CarboplatinCarboplatin is a chemotherapy agent formulated for intravenous infusion. Carboplatin will be administered (AUC 6 mg/mL*min) on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| CisplatinCisplatin is a chemotherapy agent formulated for intravenous infusion. Cisplatin will be administered (75 mg/m^2) on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| PemetrexedPemetrexed is a chemotherapy agent formulated for intravenous infusion. Pemetrexed will be administered (500 mg/m^2) on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| PaclitaxelPaclitaxel is a chemotherapy agent formulated for intravenous infusion. Paclitaxel will be administered (200 mg/m^2) on Day 1 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
| Nab-paclitaxelNab-paclitaxel is a chemotherapy agent formulated for intravenous infusion. Nab-paclitaxel will be administered (100 mg/m^2) on Day 1, 8 and 15 of each 21-day cycle | Drug | Arm A: Ociperlimab + tislelizumab + chemotherapy, Arm B: Placebo + pembrolizumab + chemotherapy, Arm C: Placebo + tislelizumab + chemotherapy |
Primary outcome
Progression-free survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment as per RECIST 1.1 in participants with PD-L1 expression in ≥1% of tumor cells (Arm A and B)
Time frame: Up to 30 months
Time from date of randomization/start of treatment to the date of event defined as the first documented progression based on BIRC assessment as per RECIST 1.1 or death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B
Overall survival (OS) in participants with PD-L1 expression in ≥1% of tumor cells (Arm A and B)
Time frame: Up to 52 months
Time from date of randomization/start of treatment to date of death due to any cause in participants with PD-L1 expression in ≥1% of tumor cells, for participants in Arm A compared to Arm B
26 secondary outcomes
PFS based on BIRC assessment as per RECIST 1.1 in all participants regardless of PD-L1 status (Arm A and B)
Time frame: Up to 30 months
OS in all participants regardless of PD-L1 status (Arm A and B)
Time frame: Up to 52 months
Overall response rate (ORR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time frame: Up to 30 months
Disease Control Rate (DCR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time frame: Up to 30 months
Time to response (TTR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time frame: Up to 30 months
Duration of response (DOR) based in BIRC assessment as per RECIST 1.1 (Arm A and B)
Time frame: Up to 30 months
ORR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time frame: Up to 30 months
DCR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time frame: Up to 30 months
TTR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time frame: Up to 30 months
DOR based in BIRC assessment as per RECIST 1.1 (Arm A and C)
Time frame: Up to 30 months
PFS based on BIRC assessment as per RECIST 1.1 (Arm A and C)
Time frame: Up to 30 months
Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of ociperlimab and tislelizumab
Time frame: Up to 30 months
PK parameter: Maximum concentration (Cmax) of ociperlimab and tislelizumab
Time frame: Up to 30 months
PK parameter: Time to reach maximum concentration (Tmax) of ociperlimab and tislelizumab
Time frame: Up to 30 months
PK parameter: Lowest serum concentration reached before the next dose is administered (Ctrough) of ociperlimab and tislelizumab
Time frame: Up to 30 months
PK parameter: AUC calculated at the end of the dosing interval (AUCtau)of ociperlimab and tislelizumab
Time frame: Up to 30 months
Immunogenicity: Anti-drug antibodies (ADA) prevalence at baseline of ociperlimab and tislelizumab
Time frame: Baseline
Immunogenicity: ADA incidence following treatment with ociperlimab and tislelizumab
Time frame: Up to 30 months
Time to definitive 10-point deterioration in physical and role functioning on the EORTC QLQ-C30 questionnaire
Time frame: Up to 30 months
Time to definitive 10-point deterioration in symptom scores for chest pain, cough and dyspnea on the EORTC QLQ-LC13 questionnaire
Time frame: Up to 30 months
Time to confirmed 10-point deterioration in physical and role functioning on the EORTC QLQ-C30 questionnaire
Time frame: Up to 30 months
Time to confirmed 10-point deterioration in symptom scores for chest pain, cough and dyspnea on the EORTC QLQ-LC13 questionnaire
Time frame: Up to 30 months
Time to definitive 10-point deterioration in global health status/quality of life, shortness of breath and pain on the EORTC QLQ-C30 questionnaire
Time frame: Up to 30 months
Utility scores of the EQ-5D-5L
Time frame: Up to 30 months
Progression-free survival deferred (PFS2)
Time frame: Up to 30 months
Time to definitive deterioration of the ECOG performance status
Time frame: Up to 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ociperlimab, Tislelizumab and Pembrolizumab in people with Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment as per RECIST 1.1 in participants with PD-L1 expression in ≥1% of tumor cells (Arm A and B) (time frame: Up to 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.