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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4.5 years
Awards & highlights
POD1UM-304 Trial Summary
This trial will test whether adding a new drug to standard platinum-based chemotherapy helps people with lung cancer live longer.
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.Check my eligibility
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.See study design
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.
POD1UM-304 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't received any systemic treatment for my advanced lung cancer.
Select...
I can provide a sample of my tumor, either previously stored or newly taken.
Select...
I am fully active or can carry out light work.
Select...
My lung cancer is confirmed to be stage IV.
POD1UM-304 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
AUC of INCMGA00012 when administered with chemotherapy
Cmax of INCMGA00012 when administered with chemotherapy
Duration of response (DOR)
+3 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
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
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Ischaemic stroke
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
POD1UM-304 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
Carboplatin
2014
Completed Phase 3
~6670
nab-Paclitaxel
2014
Completed Phase 3
~7680
Cisplatin
2013
Completed Phase 3
~1940
Retifanlimab
2018
Completed Phase 2
~320
Pemetrexed
2014
Completed Phase 3
~5250
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Zai Lab (Shanghai) Co., Ltd.Industry Sponsor
28 Previous Clinical Trials
3,098 Total Patients Enrolled
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
54,582 Total Patients Enrolled
Mark CornfieldStudy DirectorIncyte Corporation
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have early-stage cancer such as superficial bladder, skin squamous cell, or in situ cervical cancer.My organ functions are within normal ranges.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.You are expected to live for at least 3 more months.I am currently being treated for an infection or tuberculosis.I cannot take certain chemotherapy drugs due to health reasons.I have not had chest radiation of more than 30 Gy in the last 6 months.I haven't received any systemic treatment for my advanced lung cancer.I have been treated for an autoimmune disease in the last 2 years.I have not received a live vaccine within the last 30 days.I have not had major surgery in the last 3 weeks.I have not taken antibiotics or steroids in the last 7 days.I can provide a sample of my tumor, either previously stored or newly taken.I haven't had serious heart problems in the last 6 months.I do not have severe nerve damage.I have had lung conditions treated with steroids.I am fully active or can carry out light work.Your disease can be measured using a specific set of guidelines.My lung cancer is confirmed to be stage IV.
Research Study Groups:
This trial has the following groups:- Group 1: INCMGA00012 + chemotherapy (squamous NSCLC)
- Group 2: Placebo + chemotherapy (squamous NSCLC)
- Group 3: Placebo + chemotherapy (nonsquamous NSCLC)
- Group 4: INCMGA00012 + chemotherapy (nonsquamous NSCLC)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the short and long term effects of Cisplatin?
"Cisplatin has received a score of 3 from our Power team. This is due to the fact that Cisplatin is in Phase 3 clinical trials, meaning there is existing data supporting both its efficacy and safety."
Answered by AI
What are some of the conditions that Cisplatin is used to treat?
"Cisplatin is typically used to treat unresectable thymoma, but it has also been found helpful in treating mesotheliomas, refractory advanced non small cell lung cancer (nsclc), and other conditions."
Answered by AI
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