Phase 3 study of pembrolizumab SC versus pembrolizumab IV, administered with platinum doublet chemotherapy, in 1L metastatic squamous or nonsquamous NSCLC
- Conditions
- C34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lung
- Registration Number
- PER-033-21
- Lead Sponsor
- Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- In enrollment
- Sex
- All
- Target Recruitment
- 34
1. Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous 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 EGFR, ALK, or ROS1-directed therapy is not indicated (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements, OR presence of a KRAS mutation) 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. Participants are at least 18 years of age on the day of signing the informed consent.
6. Has an ECOG PS of 0 or 1 (as assessed within 7 days prior to randomization, see Appendix 10).
7. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 95 days from the last dose of chemotherapy:
- Refrain from donating sperm
- Refrain from heterosexual sex or must agree to use adequate contraception.
8. A female participant is eligible to participate if she is not pregnant or breastfeeding.
9. The participant (or legally acceptable representative) provides documented informed consent/assent for the study.
10. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
11. 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.
12. 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.
3. Has severe hypersensitivity (=Grade 3) to study intervention and/or any of its excipients (refer to the IB and/or approved product label(s) for a list of excipients).
4. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
5. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
6. Has an active infection requiring systemic therapy.
7. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority.
8. Has a known history of Hepatitis B (defined as HBsAg reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
10. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to collaborate with the requirements of the study.
11. Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
12. Before the first dose of study intervention:
- Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC.
- Has received antineoplastic biological therapy for metastatic NSCLC.
- Has had major surgery.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
13. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
14. Is expected to require any other form of antineoplastic therapy while on study.
15. Is unable to interrupt aspirin or other NSAIDs, other than an aspirin dose =1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
16. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
17. 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.
18. Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Killed vaccines are allowed.
19. Is currently participating in or has participated in a study of an inve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Welch’s t-test statistics with the log-transformed<br> NAME OF THE RESULT: Cycle 1 AUC0-3wks<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: Over a 3-week dosing interval in Cycle 1 ;Welch’s t-test statistics with the log-transformed<br> NAME OF THE RESULT: Cycle 6 Ctrough<br> PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE<br> PRIMARY RESULT: At the end of the dosing interval in Cycle 6
- Secondary Outcome Measures
Name Time Method