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Anti-PD-1 in Combination With Chemotherapy as First-Line Treatment to Lung Cancer

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ClinicalTrials.gov Identifier: NCT03432598
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is a Phase II, open-label, 4-cohort study of the monoclonal antibody BGB A317 in combination with standard platinum-based chemotherapy in subjects 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. Subjects 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., subjects with adenocarcinoma component accounting for > 50% will be allocated to non-squamous NSCLC cohort.) Subjects 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Lung Cancer; Metastatic Lung Cancer Drug: BGB-A317and Pemetrexed plus cisplatin (or carboplatin) Drug: BGB-A317 and Paclitaxel plus cisplatin (or carboplatin) Drug: BGB-A317 and Gemcitabine plus cisplatin (or carboplatin) Drug: BGB-A317 and Etoposide and cisplatin (or carboplatin) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multi-Cohort Study to Investigate the Preliminary Antitumor Activity, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB A317 in Combination With Chemotherapy as First-Line Treatment in Chinese Subjects With Locally Advanced or Metastatic Lung Cancer
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : April 2, 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Non-squamous NSCLC Drug: BGB-A317and Pemetrexed plus cisplatin (or carboplatin)
In the non-squamous NSCLC cohort, subjects will be treated with the following on Day 1 of each 21-day (3 weeks) cycle: BGB A317 200 mg IV, pemetrexed 500 mg/m² IV, and 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, BGB-A317 will be continued as scheduled, if clinically appropriate. Pemetrexed maintenance after completion of doublet chemotherapy is permitted.

Experimental: Squamous NSCLC Cohort A Drug: BGB-A317 and Paclitaxel plus cisplatin (or carboplatin)
BGB A317 200 mg IV every 3 weeks (Q3W), paclitaxel 175 mg/m² IV, and cisplatin 75 mg/m²/day IV (or carboplatin AUC 5), Q3W:. Paclitaxel plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, BGB-A317 will be continued as scheduled, if clinically appropriate.

Experimental: Squamous NSCLC Cohort B Drug: BGB-A317 and Gemcitabine plus cisplatin (or carboplatin)
BGB A317 200 mg IV Q3W on Day 1, gemcitabine 1250 mg/m² IV on Day 1 and Day 8, and cisplatin 75 mg/m²/day IV (or carboplatin AUC 5) on Day 1. Gemcitabine plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, BGB-A317 will be continued as scheduled, if clinically appropriate.

Experimental: SCLC Drug: BGB-A317 and Etoposide and cisplatin (or carboplatin)
BGB A317 200 mg IV Q3Won Day 1, etoposide 100 mg/m2 on Days 1, 2, and 3, and cisplatin 75 mg/m²/day IV (or carboplatin AUC 5) on Day 1. Etoposide and cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, BGB-A317 will be continued as scheduled, if clinically appropriate.




Primary Outcome Measures :
  1. The objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 2 years ]
    the proportion of subjects who had confirmed complete response (CR) or partial response (PR) assessed by investigator per RECIST v1.1


Secondary Outcome Measures :
  1. The incidence and severity of adverse events (AEs) according to NCI-CTCAE Version 4.03 [ Time Frame: Up to 2 years ]
  2. 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 2 years ]
  3. 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 2 years ]
  4. Disease Control Rate (DCR) - defined as the proportion of subjects who achieve CR, PR and SD using RECIST v1.1 [ Time Frame: Up to 2 years ]
  5. Pharmacokinetic evaluations of BGB-A317 in combination with chemotherapy: including but not limited to Ctrough [ Time Frame: Up to 2 years ]
  6. Anti-BGB-A317 antibody: immunogenic responses to BGB-A317 will be assessed to determine occurrence of anti-drug antibody. [ Time Frame: Up to 2 years ]
  7. The abnormality of laboratory tests according to NCI CTCAE Version 4.03 [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, aged 18-75 years on the day of signing informed consent.
  2. Have histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, squamous NSCLC, or extensive-stage SCLC.

    Note: Subjects 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. Subjects 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:

  1. Subjects with a sensitizing mutation in EGFR gene or an ALK fusion oncogene (specifically for subjects with non- squamous NSCLC). Subjects with unknown mutation/fusion status of EGFR and/or ALK must take the respective test at the investigational sites (or other designated sites) prior to enrolment.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432598


Contacts
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Contact: Wangnan Zhou +861058958000 clinicaltrials@beigene.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences Tumor Hospital Recruiting
Beijing, Beijing, China, 100021
Contact: Lijuan Zhao    861087788495    cancergcp@163.com   
Principal Investigator: Jie Wang, MD         
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Jun Huang    861088196023    hj19840804@163.com   
Principal Investigator: Jun Zhao, MD         
Beijing Chest Hospital Recruiting
Beijing, Beijing, China, 133500
Contact: Jing Liu    861089509157    liujingworkbj@126.com   
Principal Investigator: Zhe Liu, MD         
China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China, 450008
Contact: Hongxia Li    8637165588007    51lihongxia@sina.com   
Principal Investigator: Zhiyong Ma, MD         
China, Jiangsu
Jaingsu People's Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Mingmin Sun    862568136221    jsphkj@163.com   
Principal Investigator: Yongqian Shu, MD         
China, Jilin
Jilin University First Hospital Recruiting
Changchun, Jilin, China, 130021
Contact: Fei Wang    8643188786014    wangfei5780@126.com   
Principal Investigator: Ying Cheng, MD         
Jilin Cancer Hospital Recruiting
Changchun, Jilin, China, 132000
Contact: Yan Xi    8643185879120    417064629@qq.com   
Principal Investigator: Ying Cheng, MD         
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03432598     History of Changes
Other Study ID Numbers: BGB-A317-206
CTR20170361 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Etoposide
Albumin-Bound Paclitaxel
Cisplatin
Gemcitabine
Carboplatin
Etoposide phosphate
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors