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Completed

NCT Number: NCT04205812

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

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).

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Key information

Conditions

Metastatic Squamous Non-Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Metastatic Nonsquamous Non-Small Cell Lung Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundacao Pio Xii Hospital de Cancer de Barretos, Barretos, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Retifanlimab

Drug

INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

Other names: INCMGA00012

Placebo

Drug

Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

Pemetrexed

Drug

Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.

Cisplatin

Drug

Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

carboplatin

Drug

Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

paclitaxel

Drug

Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.

Nab-paclitaxel

Drug

nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.

Primary outcomes

  1. Overall Survival

    Time frame: up to 39.1 months

    Overall survival was defined as the time between the date of randomization and the date of death due to any cause.

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: up to 35.8 months

    PFS was defined as the length of time from the date of randomization until the earliest date of disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as determined by blinded independent central review (BICR), or death due to any cause, if occurring sooner than progression.

  2. Objective Response Rate

    Time frame: up to 35.78 months

    Objective response rate was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 based on BICR at any post-Baseline visit until the first progressive disease or new anticancer therapy. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

  3. Duration of Response

    Time frame: up to 34.3 months

    Duration of response was defined as the time from the earliest date of documented response until the earliest date of disease progression or death from any cause, whichever comes first, per RECIST v1.1 based on BICR. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. PD: progression of a target or non-target lesion or presence of a new lesion.

  4. Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period

    Time frame: up to approximately 39 months

    An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.

  5. Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period

    Time frame: up to approximately 39 months

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.

  6. Number of Participants With Any TEAE in the Monotherapy Treatment Period

    Time frame: up to approximately 27 months

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.

  7. Number of Participants Who Discontinued Study Drug Due to TEAEs in the Monotherapy Treatment Period

    Time frame: up to approximately 27 months

    An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as any AEs either reported for the first time or the worsening of pre-existing events after the first dose of retifanlimab/placebo and within 90 days of the last administration of the randomized period. AEs that occurred after new anticancer therapy (including monotherapy treatment) were to be excluded.

  8. Cmax1 of Retifanlimab When Administered With Chemotherapy

    Time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion

    Cmax1 was defined as the first-dose maximum serum concentration of retifanlimab.

  9. AUC1 of Retifanlimab When Administered With Chemotherapy

    Time frame: Cycle 1 Day 1: pre-infusion and immediately after infusion

    AUC1 was defined as the first-dose area under the serum concentration versus time curve.

  10. Cmaxss of Retifanlimab When Administered With Chemotherapy

    Time frame: Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.

    Cmaxss was defined as the maximum serum concentration of retifanlimab at steady state.

  11. AUCss of Retifanlimab When Administered With Chemotherapy

    Time frame: Cycle 1 Day 1 (C1D1): pre-infusion and immediately after infusion (IAI). C2D1: pre-infusion. C4D1: pre-infusion and IAI. C6D11: pre-infusion. C8D1, and every 4 cycles thereafter: pre-infusion. End of treatment visit and 30-day safety follow-up visit.

    AUCss was defined as the area under the serum concentration versus time curve at steady state.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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)

Acronym: POD1UM-304

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Dec 19, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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