A Phase 2 interventional study of Tislelizumab and Paclitaxel in Locally Advanced Lung Cancer; Metastatic Lung Cancer, sponsored by BeiGene. Completed at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB-A317 in combination with standard platinum-based chemotherapy in participants with advanced NSCLC or SCLC. The 4 cohorts will be enrolled concurrently including non-squamous NSCLC Cohort, squamous NSCLC Cohort A, squamous NSCLC Cohort B and SCLC Cohort. Participants with a mixed adenocarcinoma and squamous cell NSCLC will be allocated to one of the NSCLC cohorts based on the predominant histopathological profile. (e.g., participants with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.). Participants with squamous NSCLC will be sequentially enrolled into either of the 2 squamous NSCLC cohorts by the trial stage i.e. the sequence of the enrollment for the squamous NSCLC cohorts will be as Cohort A safety run-in Stage, followed by Cohort B safety run-in Stage, Cohort A dose-expansion stage and Cohort B dose-expansion Stage.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 32 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.
Note: Participants with mixed adenosquamous carcinoma may also be enrolled on a case-by-case basis after discussion with the medical monitors.
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Day 1 of each 21-day (3 weeks) cycle: Tislelizumab + pemetrexed + cisplatin 75 mg/m²/day IV (or carboplatin AUC 5). Pemetrexed plus cisplatin (or carboplatin) should be given for up to 4 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. Pemetrexed maintenance after completion of doublet chemotherapy is permitted.
Drug: Tislelizumab · Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin
Tislelizumab every 3 weeks (Q3W) + paclitaxel + cisplatin (or carboplatin), Q3W. Paclitaxel plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate.
Drug: Tislelizumab · Drug: Paclitaxel · Drug: Cisplatin · Drug: Carboplatin
Tislelizumab Q3W on Day 1 + gemcitabine on Day 1 and Day 8 + cisplatin IV (or carboplatin) on Day 1. Gemcitabine plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate.
Drug: Tislelizumab · Drug: Gemcitabine · Drug: Cisplatin · Drug: Carboplatin
Tislelizumab Q3W on Day 1, etoposide on Days 1, 2, and 3 + cisplatin (or carboplatin) on Day 1. Etoposide and cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate.
Drug: Etoposide · Drug: Cisplatin · Drug: Carboplatin
Administered 200 mg intravenously (IV) as specified in the treatment arm
Also known as: BGB-A317
Administered 175 mg/m² IV as specified in the treatment arm
Administered 1250 mg/m² IV as specified in the treatment arm
Administered 100 mg/m2 IV as specified in the treatment arm
Administered 500 mg/m² IV as specified in the treatment arm
Administered 75 mg/m²/day IV as specified in the treatment arm
Administered AUC 5 as specified in the treatment arm
The objective response rate (ORR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 4 years
The incidence and severity of adverse events (AEs) according to NCI-CTCAE Version 4.03
Time frame: Up to 4 years
Duration of Response (DoR) - defined as the time from the first determination of a confirmed objective response according to RECIST v1.1 until the first documentation of progression or death, whichever comes first
Time frame: Up to 4 years
Progression-Free Survival (PFS) - defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
Time frame: Up to 4 years
Disease Control Rate (DCR) - defined as the proportion of participants who achieve CR, PR and SD using RECIST v1.1
Time frame: Up to 4 years
Pharmacokinetic evaluations of BGB-A317 in combination with chemotherapy: including but not limited to Ctrough
Time frame: Up to 4 years
Anti-BGB-A317 antibody: immunogenic responses to BGB-A317 will be assessed to determine occurrence of anti-drug antibody.
Time frame: Up to 4 years
The abnormality of laboratory tests according to NCI CTCAE Version 4.03
Time frame: Up to 4 years
Plan to share: Yes
Ran from Aug 2017 to primary completion in Feb 2019, 18 months.
Of 177 industry-sponsored phase 2 interventional studies under Lung Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's 18 months is below that.
Counting every sponsor, half of 712 studies reached it within 46 months; a quarter within 30 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Tislelizumab · Etoposide