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Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective.
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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- My non-small cell lung cancer has specific genetic changes (EGFR mutations or ALK fusions).My cancer has HER2 amplification and I haven't received standard HER2 therapy.Your PD-L1 expression level is less than 1% or equal to or more than 1%.I have had treatment before that included anti-PD-1/PD-L1 therapy.My lung cancer is at an advanced stage and cannot be cured with surgery or radiation.I have had a blood clot or heart attack in the last 6 months but am stable on medication.I have had an organ or stem cell transplant.I do not have any active infections like TB, HIV, hepatitis, or COVID-19.I have never stopped an immunotherapy treatment because of severe side effects.I have not been treated with anti-TIM-3 therapy and my last treatment could include investigational drugs if combined with approved anti-PD-1/PD-L1.I haven't had lung radiotherapy in the last 4 weeks, but bone radiotherapy is okay if it was over 2 weeks ago.I have a history of lung conditions needing steroid treatment.I have not had systemic or immunotherapy as my first treatment.I do not have any serious ongoing illnesses or recent major heart issues.I have not received a live vaccine in the last 30 days.I have or had an autoimmune or inflammatory disorder.I agree to provide a fresh tumor sample and consent to a biopsy.My cancer stopped responding to immunotherapy.My cancer has a genetic change that can be treated with approved medicine.I am fully active or restricted in physically strenuous activity but can do light work.I have had severe side effects from immunotherapy or still have moderate side effects.I am 18 years old or older.I have side effects from previous treatments that are still bothersome.I have brain metastases or leptomeningeal disease causing symptoms.You have a heart condition that causes long QT syndrome or have had a prolonged QT interval due to other medications that you cannot stop taking.My organs and bone marrow are functioning well.My lung cancer can be squamous or non-squamous.I have not had any other cancer besides this one in the last 2 years.My lung cancer can be squamous or non-squamous.I have not had major surgery in the last 28 days or am still recovering from one.I haven't taken immunosuppressive drugs in the last 14 days.I am not currently undergoing any cancer treatments, except for hormone therapy for non-cancer conditions.My stomach cancer cannot be cured with surgery or radiation.You must have at least one spot that can be measured according to specific guidelines for evaluating tumor response.I can provide a tumor sample or agree to a biopsy if I join the study.My lung cancer can be squamous or non-squamous.My cancer did not respond to initial immune therapy treatments.I've had one treatment before that included anti-PD-1/PD-L1 therapy.My cancer shows PD-L1 expression of 1% or more.I've had 1-2 treatments for my condition, only one included anti-PD-1/PD-L1 therapy.Your tumor has a high level of PD-L1 expression, which is a protein related to the immune system.I can provide a sample of my tumor for the study.
- Group 1: Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1
- Group 2: Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1
- Group 3: Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1
- Group 4: Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance
- Group 5: Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1
- Group 6: Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there any vacancies open to participants in this clinical trial?
"Affirmative. The information located on clinicaltrials.gov implies that this medical trial is in the process of enrolling participants. It was initially published on September 28th 2021 and most recently updated on November 17th 2022; with 81 patients to be enrolled from 4 different locations."
Is this trial open to participants of the geriatric age range?
"According to the requirements, individuals between 18 and 130 years old can apply for this medical research. There are 21 trials specifically designed for a younger cohort while 1358 studies target elderly patients."
What benefits are anticipated from this research?
"According to AstraZeneca, the clinical trial's primary endpoint is evaluating the anti-tumour activity of AZD7789 over a span of 18 months. Additionally, secondary endpoints such as duration of response, immunogenicity and pharmacokinetic measurements will also be evaluated."
How many participants are included in this clinical experiment?
"Affirmative, according to clinicaltrials.gov the trial posted on September 28th 2021 is currently in progress. The most recent update was made on November 17th 2022 and 81 participants are hoped to be recruited from 4 different medical locations."
Are any locations in North America hosting this experiment?
"At the moment, 4 sites are taking on participants in this trial; Toronto, New york and Nashville being a few of them. To limit travelling needs during your involvement, select the closest site possible to you."
Is it possible to join this research program?
"This clinical trial is currently recruiting 81 individuals with carcinoma, non-small cell lung. To be eligible for the study, participants must meet the following criteria: age between 18 and 130; histologically or cytologically documented Stage IIIB to IV NSCLC that cannot be cured by surgery or radiation; ECOG performance status of 0 or 1; not pregnant (women) and willing to avoid pregnancy (or men willing to use highly effective contraception); adequate organ and bone marrow function measured within 28 days before first dose; squamous/non-squamous NSCLC diagnoses accepted but at least one prior line of systemic therapy containing approved PD"
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