Clinical Trial Information
Protocol: ECOG – EA5191
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Patient must be ≥ 18 years of age.
- Patient must have pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC).
- Patient must have Stage IV disease (includes M1a, M1b, or recurrent earlier stage disease), according to the 8th edition of the lung cancer TNM classification system.
- Patient must have predominant non-squamous histology (patients with NSCLC NOS are eligible). Mixed tumors will be categorized by the predominant cell type. If small cell elements are present the patient is ineligible.
- Patient’s tumor(s) must be tested and known negative for EGFR TKI sensitizing mutations (EGFR Exon 19 deletions, L858R, L861Q, G719X) and ALK gene rearrangements (by FISH, NGS, or IHC) by routine CLIA-certified clinical testing methods. Negative circulating tumor DNA results alone are not acceptable. Prior testing for tumor PD-L1 status is not required.
- Patients WITHOUT tumors with known molecular alterations in ROS1, MET, RET (see below), or must have progressed radiographically (per local investigator assessment) following one, but only one, line of platinum-based chemotherapy AND one, but only one, line of prior immunotherapy. Lines of therapy are defined by clinical or radiographic progression. Patients may have received chemotherapy and immunotherapy either concurrently or sequentially in either order. (See note in Section 3.2 for patients who received prior adjuvant chemotherapy or chemoradiation.) Patient must have received at least 2 prior doses of checkpoint inhibitor therapy in an every 2, 3, or 4 week schedule. No submission of molecular testing is required and patients may be registered for Step 0 then proceed directly to Step 1 screening.
Patients with tumors with known molecular alterations in ROS1, MET, and RETmust have progressed radiographically (per local investigator clinical assessment) on atleast one line of prior chemotherapy or targeted therapy, but there is no limit on number of prior number of therapies. Reciept of prior immunotherapy is allowed but not required.
- Patient must have measurable disease.
- Patient must have an anticipated life expectancy greater than 3 months.
- Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the following times prior to randomization/registration: Chemotherapy/targeted oral therapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to randomization/registration. Any chemotherapy administered in an every 2 week or greater schedule must be completed ≥ 2 weeks prior to randomization/registration. Additionally, patient should be recovered to equal to or less than grade 1 toxicities related to any prior treatment, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy (as determined by the treating physician).
- Patient must not have had any prior radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to randomization/registration.
- History of major surgery (within 3 months, with wound healing within 28 days, prior to randomization/registration), minor surgery (within 28 days prior to randomization/registration), other minor procedures (within 7 days prior to randomization/registration) or clinically relevant ongoing complications from prior surgery.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of study treatment.