What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those involving PD-1 inhibitors like pembrolizumab and cemiplimab, are associated with immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe toxicities, though less common, can occur. Chemotherapy, often combined with PD-1 inhibitors, typically causes nausea, vomiting, fatigue, neutropenia, and increased infection risk, with severe side effects including organ toxicity and myelosuppression.

What prior FDA approvals exist?

Several anti-PD-1 monoclonal antibodies have received FDA approval for the treatment of lung cancer. Pembrolizumab, an anti-PD-1 antibody, has been approved for use in various settings, including as monotherapy for patients with high PD-L1 expression and in combination with chemotherapy for broader patient populations. Nivolumab, another anti-PD-1 antibody, is approved for second-line treatment of advanced non-small cell lung cancer (NSCLC) after progression on platinum-based chemotherapy. Cemiplimab, also an anti-PD-1 antibody, has shown efficacy in patients with advanced NSCLC with high PD-L1 expression. These approvals highlight the effectiveness of anti-PD-1 therapies in improving overall survival and progression-free survival in lung cancer patients.

What other types of research exist?

Promising alternatives to INCMGA00012 for lung cancer patients include: 1) Nivolumab, either as monotherapy or in combination with platinum-based chemotherapy, which has shown improved survival rates in advanced NSCLC. 2) Pembrolizumab, particularly for patients with high PD-L1 expression, which has demonstrated significant benefits in progression-free and overall survival. 3) Atezolizumab, especially in combination with chemotherapy for non-squamous NSCLC, which has shown improved progression-free survival. These alternatives have been supported by various clinical trials and are considered effective options for NSCLC treatment.

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Alkylating agents

Platinum-Based Chemotherapy + INCMGA00012 for Non-Small Cell Lung Cancer (POD1UM-304 Trial)

Phase 3

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers

Untreated central nervous system metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4.5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a common cancer treatment alone or with a new drug in patients with advanced lung cancer. The chemotherapy kills cancer cells, and the new drug may help the immune system fight the cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs including lungs and intestines; infusion-related reactions; fatigue; blood disorders; increased risk of infection; nerve damage from certain chemotherapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can provide a sample of my tumor, either previously stored or newly taken.

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I am fully active or can carry out light work.

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My lung cancer is confirmed to be stage IV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am currently being treated for an infection or tuberculosis.

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I cannot take certain chemotherapy drugs due to health reasons.

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I have not had chest radiation of more than 30 Gy in the last 6 months.

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I have been treated for an autoimmune disease in the last 2 years.

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I have not received a live vaccine within the last 30 days.

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I have not had major surgery in the last 3 weeks.

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I do not have severe nerve damage.

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I have had lung conditions treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS)

Secondary study objectives

AUC of INCMGA00012 when administered with chemotherapy

Cmax of INCMGA00012 when administered with chemotherapy

Duration of response (DOR)

+3 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: INCMGA00012 + chemotherapy (squamous NSCLC)Experimental Treatment4 Interventions

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

Group II: INCMGA00012 + chemotherapy (nonsquamous NSCLC)Experimental Treatment4 Interventions

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

Group III: Placebo + chemotherapy (squamous NSCLC)Active Control4 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 Control4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Retifanlimab

2018

Completed Phase 2

~430

Pemetrexed

2014

Completed Phase 3

~5550

Carboplatin

2014

Completed Phase 3

~6120

Cisplatin

2013

Completed Phase 3

~3120

nab-Paclitaxel

2014

Completed Phase 3

~7780

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for lung cancer include chemotherapy, targeted therapies, and immune checkpoint inhibitors like anti-PD-1 monoclonal antibodies. Chemotherapy works by killing rapidly dividing cancer cells but can also affect normal cells, leading to significant side effects. Targeted therapies, such as EGFR inhibitors, specifically target genetic mutations in cancer cells, offering a more personalized treatment approach with potentially fewer side effects. Immune checkpoint inhibitors, including anti-PD-1 antibodies like INCMGA00012, enhance the body's immune response against cancer by blocking the PD-1 pathway, which tumors use to evade immune detection. This mechanism is crucial for lung cancer patients as it offers a novel approach to treatment, potentially improving outcomes and providing options for those who may not respond to traditional therapies.

EGFR mutation status in non-small cell lung cancer receiving PD-1/PD-L1 inhibitors and its correlation with PD-L1 expression: a meta-analysis.[30- and 90-day Lethality in Patients with Stage IV Lung Cancer Depending on the Primary Therapy].Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study.