Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer (POD1UM-304)

Incyte

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Nonsquamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Placebo; Drug: Paclitaxel; Drug: Cisplatin; Drug: Retifanlimab; Drug: Carboplatin; Drug: Pemetrexed; Drug: nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04205812

INCMGA 0012-304

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).

Enrollment: 583 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
• No prior systemic treatment for the advanced/metastatic NSCLC
• Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
• Measurable disease per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Willingness to avoid pregnancy or fathering children.
• Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.

Exclusion criteria

• Clinically significant cardiac disease within 6 months of start of study treatment.
• Any major surgery within 3 weeks of the first dose of study treatment.
• Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study treatment.
• History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
• Untreated central nervous system metastases and/or carcinomatous meningitis.
• Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
• Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.
• Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
• Has contraindications to chemotherapy agents used in the study.
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.
• 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).

Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.

• Has known active HBV or HCV (testing must be performed to determine eligibility)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

583 participants in 4 patient groups

INCMGA00012 + chemotherapy (nonsquamous NSCLC)

Experimental group

Description:

INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.

Treatment:

Drug: Cisplatin

Drug: Retifanlimab

Drug: Carboplatin

Drug: Pemetrexed

Placebo + chemotherapy (nonsquamous NSCLC)

Active Comparator group

Description:

Placebo with pemetrexed + cisplatin OR carboplatin followed by placebo plus pemetrexed until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.

Treatment:

Drug: Cisplatin

Drug: Placebo

Drug: Carboplatin

Drug: Pemetrexed

INCMGA00012 + chemotherapy (squamous NSCLC)

Experimental group

Description:

INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.

Treatment:

Drug: Paclitaxel

Drug: Retifanlimab

Drug: nab-Paclitaxel

Drug: Carboplatin

Placebo + chemotherapy (squamous NSCLC)

Active Comparator group

Description:

Placebo with carboplatin + paclitaxel OR nab-paclitaxel followed by placebo until progression. Participants assigned to placebo + chemotherapy will have the option of receiving open-label monotherapy INCMGA00012 in a crossover period after documentation of progressive disease.

Treatment:

Drug: Paclitaxel

Drug: Placebo

Drug: nab-Paclitaxel

Drug: Carboplatin