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Inupadenant + Chemotherapy for Non-Small Cell Lung Cancer
Study Summary
This trial tests the optimal dose & efficacy of a drug to treat advanced lung cancer patients that didn't respond to initial treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have or had lung inflammation or scarring, but only mild from previous treatment.My advanced lung cancer's PD-L1 status is known.I have serious heart problems that are not under control.I can provide a biopsy taken within the last 2 years or a new one.I haven't had cancer treatment in the last 14 days, or 28 days for immunotherapy, and I don't have severe side effects from past treatments.I agree to use effective birth control during and for 6 months after treatment.I have stomach or bowel problems that could affect how I absorb pills.My cancer has EGFR or ALK mutations, or another mutation without available targeted therapy.I have received a live vaccine recently.My cancer has returned or worsened after treatment with anti-PD-(L)1 therapy.My organs are working well.I can carry out all my daily activities without help.I have treated hepatitis B or C with no detectable virus, or I am on HIV treatment with controlled disease.I am not on medications that strongly affect drug metabolism enzymes.My lung cancer is advanced and cannot be removed by surgery.I have an autoimmune disease treated in the last 6 months or had a severe reaction to immune therapy.I have brain metastases or leptomeningeal disease that is either causing symptoms or has not been treated.I have not been on systemic therapy for an infection in the last 7 days.I have another active cancer besides the one being treated.I have an immune system disorder or I'm taking medication that weakens my immune system.I have not had minor surgery in the last week or major surgery in the last 5 weeks.I had a severe reaction to previous immune therapy that made me stop it permanently.You have a disease that can be measured using specific guidelines.
- Group 1: Part 1, open label
- Group 2: Part 2, active treatment
- Group 3: Part 2, placebo
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
What security measures are present in Part 2, active treatment to ensure patient safety?
"The safety of the active treatment Part 2 was deemed a score of 2 due to its Phase 2 status; as such, there are some data points that back up its security but nothing yet validating efficacy."
How extensive is the cohort for this medical experiment?
"Confirmed. According to clinicaltrials.gov, this medical investigation is open for enrolment and began recruiting on August 26th 2022. As of the last edit, made on November 14th 2022, a total of 192 patients need to be registered from 3 different study sites."
What are the fundamental goals of this experiment?
"This medical trial's primary objective is to evaluate the safety and tolerability of the medication. The secondary objectives include evaluating efficacy, such as overall survival, duration of response, and disease control rate - each tracked over a period up to 24 months from enrolment."
Is this research endeavor presently open for enrollment?
"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is in full swing and accepting participants since August 26th 2022. The last update was made November 14th 2022 with 192 patients required from 3 different locations."
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