Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in First-Line Metastatic Squamous NSCLC
- Conditions
- Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004721-88-AT
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 735
- Have a histologically or cytologically confirmed diagnosis squamous NSCLC. Patients with mixed histology (eg, adenosquamous) are allowed if there is squamous component in the specimen
- Have stage IV (T any, N any, M1a, M1b, or M1c as per AJCC 8th edition) squamous NSCLC
- Have measurable disease based on RECIST 1.1, as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Have not received prior systemic treatment for their advanced/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
- Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
- Have a life expectancy of at least 3 months
- Has adequate organ function; all screening laboratory tests should be performed within 10 days prior to initiation of study treatment
- Be =18 years of age on day of signing informed consent
- Male participants are eligible to participate if they agree to the following during the intervention period for at least 180 days after the
last dose of study intervention:
• Refrain from donating sperm
• Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree
to remain abstinent
OR
• Agree to use contraception, unless confirmed to be azoospermic (vasectomized or secondary to medical cause [Appendix 5]), as detailed
below:
• Agree to use male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a
woman of childbearing potential (WOCBP) who is not currently pregnant.
Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom
during each episode of penile-vaginal penetration.
- A female participant is eligible to participate if she is not pregnant (Appendix 5), not breastfeeding, and at least 1 of the following
conditions applies:
a. Not a woman of childbearing potential (WOCBP).
OR
b. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 180 days following the last dose of
pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy and agrees not to donate eggs (ova, oocytes)
to others or freeze/store for her own use for the purpose of reproduction during this period. A WOCBP must have a negative highly sensitive urine
pregnancy test as required by local regulations) within 24 hours (72 hours for serum) before the first dose of study intervention.
- Has (or legally acceptable representative if applicable) provided written informed consent/assent for the study. The participant may also provide consent/assent for Future Biomedical Research. However, the participant may participate in the main trial without participating in Future Biomedical Research
- Has a CR/PR or stable disease of their
- Non-squamous histology NSCLC
- Additional malignancy progressing or progressed within the past 3 years requiring active treatment
- Central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain metastases, and also are off steroids 3 days prior to dosing with study medication
- Autoimmune disease that has required systemic treatment in the past 2 years
- Immunodeficiency or receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or other immunosuppressive therapy within 7 days prior to first dose
- History of (noninfectious) pneumonitis requiring systemic steroids, interstitial lung disease
- Known history of active tuberculosis, HIV infection, HBV infection, or active HCV infection
- Current pneumonitis
- Prior treatment with olaparib or any other PARP inhibitor
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or agent directed to another stimulatory or co-inhibitory T cell receptor
- Prior systemic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease
- Receiving either strong or moderate inducers or inhibitor of CYP3A4 that cannot be discontinued for the duration of the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method