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)

Study of New Lung Cancer Treatment

NCT: NCT04205812 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Incyte Corporation · Started: 2020-09-11 · Est. Completion: 2026-08-28

Plain English Summary

Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer is a Phase 3 clinical trial sponsored by Incyte Corporation studying Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer. Tests a new drug (INCMGA00012) combined with chemotherapy to treat advanced lung cancer. For patients with metastatic squamous or nonsquamous non-small cell lung cancer who haven't had prior treatment. Participation involves receiving IV infusions every 3 weeks for up to 35 cycles. Alternative treatments include standard chemotherapy options like pemetrexed, cisplatin, and carboplatin. The trial aims to enroll 583 participants.

Official 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).

Who Can Participate

Here is what you need to know about eligibility for this trial. Eligible if you have advanced lung cancer, haven't had prior treatment, and can provide a tumor sample. Not eligible if you have certain heart conditions, recent surgery, or active infections. Age: 18+ years. Health: Good overall health, no major health issues. This trial is studying Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures overall survival, which means it tracks how long patients live with the treatment. The specific primary outcome measures are: Overall Survival (up to 39.1 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial aims to fill a gap in treatment options for advanced lung cancer, potentially offering a new way to extend survival. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

Market size is large, with strong competition but potential for approval given the unmet need in lung cancer treatment. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 583 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you have any health issues that might affect participation. You'll receive IV infusions every 3 weeks for up to 35 cycles. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: RANDOMIZED
  • Model: PARALLEL
  • Masking: DOUBLE
  • Enrollment: 583 participants

Interventions

  • DRUG: Retifanlimab — INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
  • 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.

Primary Outcomes

  • Overall Survival (up to 39.1 months)

Secondary Outcomes

  • Progression-free Survival (PFS) (up to 35.8 months)
  • Objective Response Rate (up to 35.78 months)
  • Duration of Response (up to 34.3 months)
  • Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the Randomized Treatment Period (up to approximately 39 months)
  • Number of Participants Who Discontinued Study Drug Due to TEAEs in the Randomized Treatment Period (up to approximately 39 months)

Full Eligibility 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)

Trial Locations

  • Pacific Cancer Medical Center, Anaheim, California, United States
  • Innovative Clinical Research Institute, Whittier, California, United States
  • Reading Hospital and Medical Center, Reading, Pennsylvania, United States
  • Fundacao Pio Xii Hospital de Cancer de Barretos, Barretos, Brazil
  • Incan - Instituto Do Cancer - Hospital Pompeia, Caxias do Sul, Brazil
  • Centro Regional Integrado de Oncologia, Fortaleza, Brazil
  • Oncosite - Centro de Pesquisa Clinica E Oncologia, Ijuí, Brazil
  • Clinica de Neoplasias Litoral Ltda, Itajaí, Brazil
  • Hospital Do Cancer de Londrina, Londrina, Brazil
  • Instituto Mederi de Pesquisa E Saude, Passo Fundo, Brazil
  • ...and 10 more locations

Frequently Asked Questions

What is clinical trial NCT04205812?

NCT04205812 is a Phase 3 INTERVENTIONAL study titled "Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer." It is currently active, not recruiting and is sponsored by Incyte Corporation. The trial targets enrollment of 583 participants.

What conditions does NCT04205812 study?

This trial investigates treatments for Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer. The primary condition under study is Metastatic Squamous Non-Small Cell Lung Cancer.

What treatments are being tested in NCT04205812?

The interventions being studied include: Retifanlimab (DRUG), Placebo (DRUG), Pemetrexed (DRUG), Cisplatin (DRUG), Carboplatin (DRUG). INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.

What does Phase 3 mean for NCT04205812?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT04205812?

This trial is currently "Active, Not Recruiting." It started on 2020-09-11. The estimated completion date is 2026-08-28.

Who is sponsoring NCT04205812?

NCT04205812 is sponsored by Incyte Corporation. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT04205812?

The trial aims to enroll 583 participants. The trial status is active, not recruiting.

How is NCT04205812 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT04205812?

The primary outcome measures are: Overall Survival (up to 39.1 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT04205812 being conducted?

This trial is being conducted at 20 sites, including Anaheim, California; Whittier, California; Reading, Pennsylvania; Barretos and 16 more sites (United States, Brazil, Bulgaria).

Where can I find official information about NCT04205812?

The official record for NCT04205812 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04205812. This government database provides the most up-to-date and detailed information about the trial.

What is NCT04205812 testing in simple terms?

Tests a new drug (INCMGA00012) combined with chemotherapy to treat advanced lung cancer. For patients with metastatic squamous or nonsquamous non-small cell lung cancer who haven't had prior treatment.

Why is this trial significant?

This trial aims to fill a gap in treatment options for advanced lung cancer, potentially offering a new way to extend survival. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT04205812?

Potential side effects include nausea, fatigue, and immune-related issues like inflammation. Monitor your health closely and report any new symptoms to your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT04205812?

Ask your doctor if you have any health issues that might affect participation. You'll receive IV infusions every 3 weeks for up to 35 cycles. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT04205812 signal from an investment perspective?

Market size is large, with strong competition but potential for approval given the unmet need in lung cancer treatment. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves receiving IV infusions every 3 weeks for up to 35 cycles. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.