NSCLC, Stage IIIPhase 2NCT05611879
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
A Phase 2 study testing Tislelizumab, Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) and Carboplatin in people with NSCLC, Stage III, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC, Stage III
- What is being tested?
- Tislelizumab, Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2023to 30 Apr 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent provided.
- Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
- ECOG score is 0 or 1.
- Adequate hematological function, liver function and renal function.
Who cannot join
- Previously received systemic anti-tumor therapy for non-small cell lung cancer.
- history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
- History or active pulmonary tuberculosis.
- Active infections that require systemic treatment.
- History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
- Untreated active Hepatitis B.
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- Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
- Grade 3 or above peripheral neuropathy.
- Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
- Underlying severe or uncontrolled disease.
- Malignant tumors other than NSCLC within 5 years.
- Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality
Fan Yang, Dr., +86-10-56112345, Yfa01087@btch.edu.cn
About this study
Official title: Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial
The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.
- Conditions
- NSCLC, Stage III
- Being tested
- Tislelizumab, Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC), Carboplatin
- 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.
TislelizumabDrug
Tislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles
Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)Drug
Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles.
CarboplatinDrug
AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery | Experimental | Participants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection. Receives: Drug: Tislelizumab; Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Measured: At time of surgery
Secondary outcomes (4)
Major pathological response rate (MPR)
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Measured: At time of surgery
Pathology complete response rate(pCR)
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Measured: At time of surgery
R0 Resection rate
R0 Resection rate is defined as the percentage of patients who were able to undergo R0 Resection surgery after neoadjuvant therapy.
Measured: At time of surgery
Perioperative G3-4 Adverse Events (AEs)
The number of participants experiencing an perioperative G3-4 AE will be assessed.
Measured: Up to 1 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start12 Mar 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC, Stage IIIStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donghong Chen, Dr., Principal investigator, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611879
- Sponsor's protocol ID
- 21416-0-02
- Status last verified
- Dec 2023
- First submitted
- 4 Nov 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT05611879
- Acronym / sponsor ID
- 21416-0-02
- Conditions
- NSCLC, Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 10 Nov 2022 (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 purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery | Experimental | Drug: Tislelizumab, Drug: Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC), Drug: CarboplatinParticipants will receive neoadjuvant Tislelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent provided.
- Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
- ECOG score is 0 or 1.
- Adequate hematological function, liver function and renal function.
Key exclusion criteria (12 listed)
- Previously received systemic anti-tumor therapy for non-small cell lung cancer.
- history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
- History or active pulmonary tuberculosis.
- Active infections that require systemic treatment.
- History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
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 |
|---|---|---|
| TislelizumabTislelizumab: 200mg, IV, day 1 of each 21-day cycle, Neoadjuvant therapy : 3 cycles | Drug | Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery |
| Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC)Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Paclitaxel: 60-75mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. | Drug | Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery |
| CarboplatinAUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 2. | Drug | Neoadjuvant therapy of Tislelizumab with chemotherapy+surgery |
Primary outcome
Resectability rate
Time frame: At time of surgery
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
4 secondary outcomes
Major pathological response rate (MPR)
Time frame: At time of surgery
Pathology complete response rate(pCR)
Time frame: At time of surgery
R0 Resection rate
Time frame: At time of surgery
Perioperative G3-4 Adverse Events (AEs)
Time frame: Up to 1 month post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Donghong Chen, Dr. principal investigator
Beijing Tsinghua Chang Gung Hospital
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 Tislelizumab, Pemetrexed (Nonsquamous NSCLC) or Paclitaxel/Nab-paclitaxel(Squamous NSCLC) and Carboplatin in people with NSCLC, Stage III, run by Beijing Tsinghua Chang Gung Hospital 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Yang, Dr. (+86-10-56112345, Yfa01087@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectability rate (time frame: At time of surgery). 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 29 Dec 2023.