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-PL
- 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
- Has (or legally acceptable representative) provided documented
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 NSCLC as determined by central
imaging review after completion of study-specified Induction Phase
- Have an ECOG performance status score of 0 or 1 as assessed at Prerandomization
visit (most recent assessment within this visit).
- All AEs (with the exception of alopecia, Grade 2 fatigue, and Grade =2
endocrine-related AEs requiring treatment or hormone replacement. For
anemia and creatinine clearance, the guidelines provided in Table 3 may
be followed) resolved to Grade =1 or baseline following Induction Phase
treatment.
- Have adequate organ function, as indicated by the laboratory values in
Table 3 above.
- Are not taking medications or vaccinations specifically prohibited
- Are not pregnant or breastfeeding or expecting to conceive or father
children within the projected duration of the study, starting from the
pre-randomization visit through 180 days after the last dose of study
intervention.
- Have not withdrawn consent to continue treatment.
- Continue to derive clinical benefit from study participation according to
investigator's discretion
- 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
- 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