Non-squamous Non-small-cell Lung CancerPhase 2NCT05849246
The Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
A Phase 2 study testing Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed, Sintilimab+Carboplatin or Cisplatin+Pemetrexed and Tusamitamab ravtansine+Sintilimab in people with Non-squamous Non-small-cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
Primary objective： ·To assess the antitumor activity of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed, Sintilimab+Carboplatin or Cisplatin+Pemetrexed and Tusamitamab ravtansine+Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2023to 22 Dec 2023
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I1. Age ≥ 18 years and < 75 years males of females.
- I2. Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation, BRAF mutation or ALK/ROS alterations.
- I3. No prior systemic therapy for the treatment of advanced or metastatic disease.
- I4. Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC assay with ≥ 2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not, available fresh biopsy sample will be collected if considered an acceptable risk by the treating physician).
- I5. Adequate hematologic/liver/renal/coagulation function.
- I6. Life expectancy exceeds 3 months.
- I7. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- E1. Hstologically or cytologically confirmed mixed NSCLC with small-cell or prodominant squamous carcinoma components.
- E2. Unstable brain metastases and history of leptomeningeal disease.
- E3. Significant concomitant illness, including any severe medical conditions that, in the opinion of the investigator or sponsor, would impair the subject's participation in the study or interpretation of the results.
- E4. History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- E5. History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B (defined as either positive HBsAg or positive hepatitis B viral DNA test above the lower limit of detection of the assay), or C (defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay) infection.
- E6. History of active autoimmune disease that has required systemic treatment in the past 2 years.
Show all 10Show fewer
- E7. Non-resolution of any prior treatment-related toxicity to < Grade 2 according to NCI CTCAE V5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone-replacement therapy.
- E8. Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted. Patients using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.
- E9. Received traditional Chinese medicine with anti-tumor indications within 2 weeks prior the first administration, or received immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for pleural effusion control) within 2 weeks prior administration.
- E10. Have received prior systemic therapy for advanced/metastatic NSCLC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Primary objective：
·To assess the antitumor activity of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
Read more
Secondary objectives： To assess the safety and tolerability of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
To assess the pharmacokinetic (PK) characteristic of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
Read the detailed description
The expected duration of the study intervention for participants may vary based on progression date; median expected duration of study per participant is estimated 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for end-of-treatment assessments and safety follow-up visit).
- Conditions
- Non-squamous Non-small-cell Lung Cancer
- Being tested
- Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed, Sintilimab+Carboplatin or Cisplatin+Pemetrexed, Tusamitamab ravtansine+Sintilimab
- Keywords
- CEACAM5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+PemetrexedDrug
Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous.
Other Name: Tusamitamab ravtansine. Other Name: Tyvyt®
Sintilimab+Carboplatin or Cisplatin+PemetrexedDrug
Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
Tusamitamab ravtansine+SintilimabDrug
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous.
Other Name: Tusamitamab ravtansine. Other Name: Tyvyt®
| Study group | Role | What they receive |
|---|---|---|
| tusamitamab ravtansine + sintilimab | Experimental | Sintilimab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks. Receives: Drug: Tusamitamab ravtansine+Sintilimab |
| Tusamitamab ravtansine + Sintilimab + carboplatin/ cisplatin + pemetrexed | Experimental | Sintilimab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin / cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Receives: Drug: Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed |
| Sintilimab + carboplatin/ cisplatin + pemetrexed | Placebo comparator | Pemetrexed will be infused over 10 minutes after Sintilimab infusion on Day 1 and then Q3W. Carboplatin/ cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. Receives: Drug: Sintilimab+Carboplatin or Cisplatin+Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) per RECIST 1.1 by investigators.
ORR is defined as proportion of participants who have a confirmed complete
Measured: 3 years
Secondary outcomes (6)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities
TEAEs, SAEs and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Measured: 3 years
Pharmacokinetic concentrations of tusamitamab ravtansine (IBI126)
Measured: 3 years
Duration of Response (DoR)
DoR is defined the time when subject reaches complete or partial response for the first time to the progression of the disease.
Measured: 3 years
Progression-free Survival (PFS)
Measured: 3 years
Time to Response (TTR)
Measured: 3 years
Disease Control Rate (DCR)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start31 Jul 2023
- Primary completion30 Nov 2023
- Study completion22 Dec 2023
Why it stopped: strategy terminates development, the decision is not due to any safety-related issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849246
- Sponsor's protocol ID
- CIBI126A201
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase 2 Study of Tusamitamab Ravtansine (IBI126) Combined With Sintilimab and Tusamitamab Ravtansine (IBI126) Combined With Sintilimab Plus Platinum-based Chemotherapy and Pemetrexed in Subjects With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
- ClinicalTrials.gov ID
- NCT05849246
- Acronym / sponsor ID
- CIBI126A201
- Conditions
- Non-squamous Non-small-cell Lung Cancer
- Keywords
- CEACAM5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: strategy terminates development, the decision is not due to any safety-related issues
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 8 May 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.
Primary objective：
·To assess the antitumor activity of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
Secondary objectives： To assess the safety and tolerability of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
To assess the pharmacokinetic (PK) characteristic of tusamitamab ravtansine in combination with sintilimab and tusamitamab ravtansine in combination with sintilimab, platinum-based chemotherapy and pemetrexed in the NSQ NSCLC population.
Detailed description
The expected duration of the study intervention for participants may vary based on progression date; median expected duration of study per participant is estimated 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for end-of-treatment assessments and safety follow-up visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tusamitamab ravtansine + sintilimab | Experimental | Drug: Tusamitamab ravtansine+SintilimabSintilimab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks. |
| Tusamitamab ravtansine + Sintilimab + carboplatin/ cisplatin + pemetrexed | Experimental | Drug: Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+PemetrexedSintilimab dose will be administered intravenously prior to intravenous adminstration of tusamitamab ravtansine dose every 3 weeks. Pemetrexed will be infused over 10 minutes after tusamitamab ravtansine infusion on Day 1 and then Q3W. Carboplatin / cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. |
| Sintilimab + carboplatin/ cisplatin + pemetrexed | Placebo comparator | Drug: Sintilimab+Carboplatin or Cisplatin+PemetrexedPemetrexed will be infused over 10 minutes after Sintilimab infusion on Day 1 and then Q3W. Carboplatin/ cisplatin will be infused over 15 to 60 minutes immediately after pemetrexed infusion on Day 1 and Q3W for the first 4 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- I1. Age ≥ 18 years and < 75 years males of females.
- I2. Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation, BRAF mutation or ALK/ROS alterations.
- I3. No prior systemic therapy for the treatment of advanced or metastatic disease.
- I4. Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC assay with ≥ 2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not, available fresh biopsy sample will be collected if considered an acceptable risk by the treating physician).
- I5. Adequate hematologic/liver/renal/coagulation function.
Key exclusion criteria (10 listed)
- E1. Hstologically or cytologically confirmed mixed NSCLC with small-cell or prodominant squamous carcinoma components.
- E2. Unstable brain metastases and history of leptomeningeal disease.
- E3. Significant concomitant illness, including any severe medical conditions that, in the opinion of the investigator or sponsor, would impair the subject's participation in the study or interpretation of the results.
- E4. History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- E5. History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B (defined as either positive HBsAg or positive hepatitis B viral DNA test above the lower limit of detection of the assay), or C (defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay) infection.
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 |
|---|---|---|
| Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+PemetrexedPharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous. Other Name: Tusamitamab ravtansine. Other Name: Tyvyt® | Drug | Tusamitamab ravtansine + Sintilimab + carboplatin/ cisplatin + pemetrexed |
| Sintilimab+Carboplatin or Cisplatin+PemetrexedPharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous | Drug | Sintilimab + carboplatin/ cisplatin + pemetrexed |
| Tusamitamab ravtansine+SintilimabPharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous. Other Name: Tusamitamab ravtansine. Other Name: Tyvyt® | Drug | tusamitamab ravtansine + sintilimab |
Primary outcome
Overall Response Rate (ORR) per RECIST 1.1 by investigators.
Time frame: 3 years
ORR is defined as proportion of participants who have a confirmed complete
6 secondary outcomes
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities
Time frame: 3 years
Pharmacokinetic concentrations of tusamitamab ravtansine (IBI126)
Time frame: 3 years
Duration of Response (DoR)
Time frame: 3 years
Progression-free Survival (PFS)
Time frame: 3 years
Time to Response (TTR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Results and safety
The study was stopped early (reason given: strategy terminates development, the decision is not due to any safety-related issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Related trials for Non-squamous Non-small-cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tusamitamab ravtansine+Sintilimab+Carboplatin or Cisplatin+Pemetrexed, Sintilimab+Carboplatin or Cisplatin+Pemetrexed and Tusamitamab ravtansine+Sintilimab in people with Non-squamous Non-small-cell Lung Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
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 7 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: strategy terminates development, the decision is not due to any safety-related issues). Results are not available in the source record.
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?
Overall Response Rate (ORR) per RECIST 1.1 by investigators. (time frame: 3 years). 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 20 Aug 2024.