Platinum-Based Chemotherapy + INCMGA00012 for Non-Small Cell Lung Cancer

(POD1UM-304 Trial)

Recruiting at 217 trial locations

Overseen By Incyte Corporation Call Center (US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Must not be taking: Antibiotics, Steroids, others

Disqualifiers: Cardiac disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 39 months

583 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of adding a new drug, INCMGA00012 (also known as Retifanlimab, an experimental treatment), to standard platinum-based chemotherapy for individuals with advanced non-small cell lung cancer (NSCLC). Researchers aim to determine if this combination is more effective than chemotherapy alone in treating both squamous and nonsquamous types of NSCLC, which have spread to other parts of the body. Participants should have a diagnosis of advanced NSCLC and must not have received previous treatment for this stage of their cancer. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of INCMGA00012, also known as retifanlimab, with platinum-based chemotherapy has been studied in patients with non-small cell lung cancer (NSCLC). These studies found that this combination can extend patient survival compared to chemotherapy alone. Importantly, the treatment is generally well-tolerated, meaning most patients can handle it without severe issues.

For patients with squamous NSCLC, retifanlimab combined with chemotherapy produced side effects similar to those of standard platinum-based chemotherapy.

For those with nonsquamous NSCLC, the results were similar. The combination with chemotherapy improved patient outcomes without causing significant new safety concerns.

In both types of NSCLC, while side effects can occur, they align with typical expectations for these cancer treatments. Overall, studies have found the treatment to be safe for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about INCMGA00012 for non-small cell lung cancer because it offers a new approach compared to the standard chemotherapy options like carboplatin, cisplatin, and paclitaxel. INCMGA00012 is a unique immunotherapy that works by targeting and blocking PD-1, a protein on immune cells, which helps the body’s immune system recognize and attack cancer cells more effectively. Unlike traditional chemotherapy that directly kills cancer cells, INCMGA00012 boosts the immune response against the cancer. This innovative mechanism has the potential to improve outcomes for patients, offering a promising advancement in lung cancer treatment.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will evaluate the effectiveness of combining INCMGA00012 with platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC). Participants with squamous NSCLC may receive INCMGA00012 with chemotherapy, which studies have shown can help patients live longer without their cancer worsening. For those with nonsquamous NSCLC, the trial will also test INCMGA00012 with chemotherapy, as research has indicated significant improvement compared to chemotherapy alone. This combination not only delays cancer progression but also helps patients live longer overall. These findings suggest that using INCMGA00012 with standard chemotherapy could be a promising treatment option for advanced NSCLC. ^{1 2 3 5 6}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) who haven't had systemic treatment for it. They should expect to live at least 3 months, have good organ function, and be able to provide a tumor sample. Participants must not be pregnant or fathering children, have certain infections or recent major surgery, untreated brain metastases, significant heart issues, severe neuropathy, or active autoimmune diseases.

Inclusion Criteria

My organ functions are within normal ranges.

You are expected to live for at least 3 more months.

I haven't received any systemic treatment for my advanced lung cancer.

Exclusion Criteria

I have early-stage cancer such as superficial bladder, skin squamous cell, or in situ cervical cancer.

I have brain metastases or cancer in the lining of my brain that hasn't been treated.

You have a known active hepatitis B or C infection. Testing is needed to check for this.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive platinum-based chemotherapy with or without INCMGA00012 until disease progression

up to 39 months

Crossover

Participants on placebo may receive open-label INCMGA00012 monotherapy after disease progression

up to 27 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 39 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cisplatin
• INCMGA00012
• nab-Paclitaxel
• Paclitaxel
• Pemetrexed

Trial Overview The study tests the effectiveness of platinum-based chemotherapy combined with INCMGA00012 (an anti-PD-1 antibody) versus chemotherapy alone in treating NSCLC. Patients will receive either Carboplatin or Cisplatin along with drugs like nab-Paclitaxel or Pemetrexed and are randomly assigned to also get INCMGA00012 or a placebo.

How Is the Trial Designed?

Group I: INCMGA00012 + chemotherapy (squamous NSCLC) Experimental Treatment 4 Interventions

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

Group II: INCMGA00012 + chemotherapy (nonsquamous NSCLC) Experimental Treatment 4 Interventions

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

Group III: Placebo + chemotherapy (squamous NSCLC) Active Control 4 Interventions

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.

Group IV: Placebo + chemotherapy (nonsquamous NSCLC) Active Control 4 Interventions

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.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Zai Lab (Shanghai) Co., Ltd.

Industry Sponsor

Trials

30

Recruited

3,800+

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-positive-results-phase-3-trial-evaluating

Incyte Announces Positive Results from Phase 3 Trial ... The POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40983066/

Retifanlimab versus placebo in combination with platinum- ... We aimed to evaluate the efficacy of the PD-1 inhibitor retifanlimab plus platinum-based chemotherapy as first-line treatment for non-squamous or squamous ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04205812

Study Details | NCT04205812 | Platinum-Based ... The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04716-1/fulltext

627MO POD1UM-304: Phase III study of retifanlimab plus ... POD1UM-304 evaluated the efficacy of retifanlimab, a PD-1 inhibitor, plus platinum-based chemo as 1L treatment (tx) for nonsquamous or squamous mNSCLC. Methods.

5. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(25)00209-7/abstract

Retifanlimab versus placebo in combination with platinum- ... Retifanlimab improved overall survival compared with placebo when added to platinum-based chemotherapy, with a safety profile that is ...

6. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04205812/

Clinical Trial: NCT04205812 The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic ...