RecruitingAdvanced Lung Non-Small Cell CarcinomaStage IIIB Lung Cancer AJCC v8Stage IIIC Lung Cancer AJCC v8

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

Eligible age

70+ yrs

Accepts

All genders

Locations

37 states

Healthy volunteers

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About this study

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ STEP 1 REGISTRATION
✓ Patient must be ≥ 70 years of age
✓ Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
✓ Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
✓ Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
✓ Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
✓ Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
✓ Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible