Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer
NCT ID: NCT03432598
Last Updated: 2024-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2017-08-24
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-squamous NSCLC
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.
Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Pemetrexed
Administered 500 mg/m² IV as specified in the treatment arm
Cisplatin
Administered 75 mg/m²/day IV as specified in the treatment arm
Carboplatin
Administered AUC 5 as specified in the treatment arm
Squamous NSCLC Cohort A
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.
Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Paclitaxel
Administered 175 mg/m² IV as specified in the treatment arm
Cisplatin
Administered 75 mg/m²/day IV as specified in the treatment arm
Carboplatin
Administered AUC 5 as specified in the treatment arm
Squamous NSCLC Cohort B
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.
Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Gemcitabine
Administered 1250 mg/m² IV as specified in the treatment arm
Cisplatin
Administered 75 mg/m²/day IV as specified in the treatment arm
Carboplatin
Administered AUC 5 as specified in the treatment arm
SCLC
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.
Etoposide
Administered 100 mg/m2 IV as specified in the treatment arm
Cisplatin
Administered 75 mg/m²/day IV as specified in the treatment arm
Carboplatin
Administered AUC 5 as specified in the treatment arm
Interventions
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Tislelizumab
Administered 200 mg intravenously (IV) as specified in the treatment arm
Paclitaxel
Administered 175 mg/m² IV as specified in the treatment arm
Gemcitabine
Administered 1250 mg/m² IV as specified in the treatment arm
Etoposide
Administered 100 mg/m2 IV as specified in the treatment arm
Pemetrexed
Administered 500 mg/m² IV as specified in the treatment arm
Cisplatin
Administered 75 mg/m²/day IV as specified in the treatment arm
Carboplatin
Administered AUC 5 as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Have had no prior systemic therapy for advanced or metastatic disease. Prior neoadjuvant/adjuvant therapy or chemoradiation therapy with curative intent should have been completed at least 6 months prior to documentation of recurrence of disease.
4. Participants must be able to provide fresh or archival tumor tissues (formalin-fixed paraffin-embedded \[FFPE\] blocks or at least 10 unstained FFPE slides) with an associated pathological report.
Exclusion Criteria
2. Prior malignancy active within the previous 2 years exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
3. Prior therapies targeting PD-1, PD-L1 or PD-L2
18 Years
75 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Jie Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Countries
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References
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Wang Z, Zhao J, Ma Z, Cui J, Shu Y, Liu Z, Cheng Y, Leaw SJ, Wu Y, Ma Y, Tan W, Ma X, Zhang Y, Wang J. A Phase 2 Study of Tislelizumab in Combination With Platinum-Based Chemotherapy as First-line Treatment for Advanced Lung Cancer in Chinese Patients. Lung Cancer. 2020 Sep;147:259-268. doi: 10.1016/j.lungcan.2020.06.007. Epub 2020 Jun 20.
Other Identifiers
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CTR20170361
Identifier Type: REGISTRY
Identifier Source: secondary_id
BGB-A317-206
Identifier Type: -
Identifier Source: org_study_id
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