A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non–Small Cell Lung Cancer (POD1UM-304)

Phase 1

Recruiting

• Conditions: Metastatic nonsquamous or squamous non-small cell lung cancer; MedDRA version: 20.0Level: LLTClassification code: 10079440Term: Non-squamous non-small cell lung cancer Class: 10029104; MedDRA version: 24.0Level: LLTClassification code: 10085300Term: Squamous non-small cell lung cancer Class: 100000004848; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501987-16-00
• Lead Sponsor: Incyte Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-11
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study., Has adequate organ function as indicated by the laboratory values in Table 7. Specimens must be collected and reviewed within 10 days prior to the start of study treatment., Has had an evaluation by the investigator regarding vaccination against SARS-CoV-2 before study entry. Note: Vaccination before study entry is a strong recommendation, not a requirement. Potential participants and the investigator should discuss up-to-date information according to national or local vaccination programs and/or oncology professional guidelines., Is at least 18 years of age on the day of signing the ICF (or as applicable per local country requirements), Has histologically or cytologically confirmed diagnosis of NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8). a. Documentation for absence of driver mutations or gene rearrangements for EGFR, ALK, BRAF, and ROS1 if the tumor is of nonsquamous histology. Note: If documentation does not exist for all 4 driver mutations, then archived or fresh tumor tissue material must be tested locally, or centrally arranged by the sponsor. Detailed information is found in the Laboratory Manual. b. If participant's tumor is known to have a predominantly squamous histology, molecular testing for EGFR mutation, ALK, BRAF, and ROS1 translocations will not be required, as this is not part of current diagnostic guidelines. c. Tumor with mixed histology will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible. In cases where it is not completely known, testing must occur., No prior systemic treatment for the advanced/metastatic NSCLC with the exception of neoadjuvant or adjuvant therapy that did not include a PD-(L)1 directed therapy and completed at least 12 months before the development of metastatic disease. Note: Only participants without access (due to inadequate reimbursement, labelling restrictions, or any other reason) to the best standard treatment options (eg, an approved PD-(L)1 inhibitor in combination with chemotherapy or monotherapy) that, according to the investigator, could benefit the participant more can be included in the study. If the best approved and reimbursed standard treatment options become available during the study, the participant may discontinue from study treatment if the investigator and the participant believe that the participant could benefit more by switching to the approved and reimbursed standard treatment., Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy after a participant has been diagnosed with metastatic disease, for central confirmation of PD-L1 status. Note: Biopsy should be from a tumor site that has not been treated with radiation. Formalin-fixed archival specimens after the participant has been diagnosed with metastatic disease will be preferred for determination of PD-L1 status (and driver mutations if needed) prior to randomization, Has measurable disease per RECIST v1.1 as determined by 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 an ECOG performance status of 0 or 1 at study entry, Has a life expectancy of at least 3 months before signing the ICF, Willingness to avoid pregnancy or fathering children based on the criteria below: a. M

Exclusion Criteria

Is currently participating and receiving investigational therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment., Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions is eligible, Has known active HBV or HCV as defined in protocol, Has a known history of HIV infection. HIV testing is not required unless mandated by the local health authority, or local regulations, Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 3 years since initiation of that therapy, Has had an allogeneic tissue/solid organ transplant, Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of INCMGA00012 or as applicable, to carboplatin, cisplatin, paclitaxel, nab-paclitaxel, or pemetrexed., Is unable to interrupt aspirin or other NSAIDS, other than an aspirin dose = 1.3 g per day, for a 5-day period (8-day period for long acting agents), Is unable or unwilling to take folic acid or vitamin B12 supplementation, 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 allowed, Is receiving systemic antibiotics or steroid therapy = 7 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication. a. Corticosteroid use after randomization is allowed for management of AEs, SAEs, as a premedication for IV contrast, or if considered necessary for a participant's welfare. b. Participants who receive daily steroid replacement therapy = 10 mg prednisone or equivalent are exempt. c. Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate (are allowed to participate). d. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate, Received prior systemic cytotoxic chemotherapy, targeted or biological therapy for metastatic disease therapy with an anti–PD-1/PDL1/PD-L2, anti-CD137, or anticytotoxic T-lymphocyte–associated antigen-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways., Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug). a. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine, Current use of any prohibited medication as described in Section 6.6.3, Has a history or current evidence of any condition including psychiatric or substance abuse disorders, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's ability to participate, or cooperate, 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, Has clinically significant or impaired c

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified