Phase 3 study of pembrolizumab SC versus pembrolizumab IV, administered with platinum doublet chemotherapy, in 1L metastatic squamous or nonsquamous NSCLC
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2021210032
- Lead Sponsor
- Ishii Takeaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
2. Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
3. Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
4. Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease
5. Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1
6. Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic
7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol. Patients who stop breastfeeding at the start of the study but wish to resume breastfeeding thereafter during participation in the study are not eligible.
8. Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
9. Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization
10. Has adequate organ function
1. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
2. Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment
3. Has severe hypersensitivity to study intervention and/or any of its excipients
4. Has an active autoimmune disease that has required systemic treatment in past 2 years
5. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
6. Has an active infection requiring systemic therapy
7. Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection
8. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
9. Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible
10. Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
11. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention
12. Is expected to require any other form of antineoplastic therapy while on study
13. For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose =<1.3 g/day, for a 5-day period
14. For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation
15. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=<2 weeks of radiotherapy) to non-CNS disease
16. Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
18. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
19. Has had an allogenic tissue/solid organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1 <br>- Minimal Concentration (Ctrough) of Pembrolizumab at the End of Cycle 6
- Secondary Outcome Measures
Name Time Method - Objective Response, Progression-Free Survival and Duration of Response per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) <br>- Maximum Concentration (Cmax) and Ctrough at the End of Cycle 1 of Pembrolizumab at Cycle 1 <br>- AUC 0-3wks and Cmax of Pembrolizumab at Cycle 6 <br>- Safety and Tolerability <br>- Overall Survival (OS) <br>- Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab