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

(POD1UM-304 Trial)

Recruiting at 174 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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+