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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04205812
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : July 28, 2022
Sponsor:
Collaborator:
Zai Lab (Shanghai) Co., Ltd.
Information provided by (Responsible Party):
Incyte Corporation

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Metastatic Squamous Non-Small Cell Lung Cancer Metastatic Nonsquamous Non-Small Cell Lung Cancer Drug: Retifanlimab Drug: Placebo Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Drug: nab-Paclitaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : September 27, 2020
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: INCMGA00012 + chemotherapy (nonsquamous NSCLC)
INCMGA00012 with pemetrexed + cisplatin OR carboplatin followed by INCMGA00012 plus pemetrexed until progression.
 Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Other Name: INCMGA00012

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

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

Drug: Carboplatin
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Active Comparator: Placebo + chemotherapy (nonsquamous NSCLC)
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.
 Drug: Placebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

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

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

Drug: Carboplatin
Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
Experimental: INCMGA00012 + chemotherapy (squamous NSCLC)
INCMGA00012 with carboplatin + paclitaxel OR nab-paclitaxel followed by INCMGA00012 until progression.
 Drug: Retifanlimab
INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
Other Name: INCMGA00012

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

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

Drug: nab-Paclitaxel
nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
Active Comparator: Placebo + chemotherapy (squamous NSCLC)
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.
 Drug: Placebo
Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

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

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Approximately 4.5 years. ]
    Defined as the time from randomization until death due to any cause.

  2. Progression-free survival (PFS) [ Time Frame: Approximately 4.5 years. ]
    Defined as the time from randomization until 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.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Approximately 4.5 years. ]
    Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1 based on BICR.

  2. Duration of response (DOR) [ Time Frame: Approximately 4.5 years. ]
    Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1 based on BICR) or death from any cause, whichever comes first.

  3. Number of treatment-emergent adverse events [ Time Frame: Approximately 4.5 years. ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 90 days after last dose of study treatment.

  4. Cmax of INCMGA00012 when administered with chemotherapy [ Time Frame: Approximately 4.5 years. ]
    Maximum observed plasma or serum concentration.

  5. AUC of INCMGA00012 when administered with chemotherapy [ Time Frame: Up to approximately 4.5 years. ]
    Area under the plasma or serum concentration curve.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04205812


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
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Sponsors and Collaborators
Incyte Corporation
Zai Lab (Shanghai) Co., Ltd.
Investigators
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Study Director: Mark Cornfield Incyte Corporation
More Information
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04205812    
Other Study ID Numbers: INCMGA 0012-304
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: July 28, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Metastatic
non-small cell lung cancer
nonsquamous
 squamous
PD-1
PD-L1
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
 Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors