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Monoclonal Antibodies
Durvalumab + Tremelimumab ± Chemotherapy for Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing durvalumab with or without tremelimumab to see if it works better than other treatments.
Who is the study for?
Adults with stage IV non-small cell lung cancer (NSCLC), either squamous or non-squamous, who haven't had prior immune therapy or certain other treatments. They must have good organ function, no serious illnesses that could interfere with the trial, and not be pregnant. Participants need to agree to use effective contraception and complete quality of life questionnaires.
What is being tested?
The study is testing Durvalumab and Tremelimumab immunotherapies, alone or combined with platinum-based chemotherapy. These drugs help the immune system recognize and fight cancer cells. The trial will assess their effectiveness in slowing down cancer growth compared to standard treatments.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses during drug administration, fatigue, digestive issues like nausea or diarrhea, blood disorders such as anemia or clotting problems, and increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Objective Response Rate Using RECIST 1.1 and iRECIST
Progression-free Survival Using RECIST 1.1
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Durvalumab and TremelimumabActive Control2 Interventions
Durvalumab q4 weeks until PD + Tremelimumab q 4 wk x 4 doses
Group II: Platinum based chemotherapy + Durvalumab + TremelimumabActive Control3 Interventions
4 cycles platinum plus gem or pem + Durva + Treme (q 3 wk x 4 cycles)
Followed by:
Squamous Cell: Maintenance Durva q 4 wk until PD Non-Squamous Cell: Pemetrexed + Durva q 4 wk until PD
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,566 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,355 Total Patients Enrolled
Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER
194 Previous Clinical Trials
161,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no allergies to durvalumab, tremelimumab, or their ingredients, and I've managed previous cancer treatments without severe reactions or needing steroids.I am fully active or restricted in physically strenuous activity but can do light work.My heart's electrical activity (QTcF) is normal or I don't have a family history of long QT syndrome.My brain metastases are treated, stable, and I'm not on steroids.I had cancer before, but it was either non-melanoma skin cancer, cervical in-situ cancer, or another type that was treated over 3 years ago with no signs of return.I have had an autoimmune or inflammatory disorder in the last 3 years.I have not received any live vaccines in the last 30 days.I have never had a severe reaction to immune therapy or been on recent immunosuppressants.My liver function tests are within the required range.I finished my adjuvant therapy for fully removed cancer over a year ago.My cancer is at stage IV.My cancer has grown in areas not previously treated with radiation.I had radiation therapy, but it ended at least 2 weeks ago and I'm not currently receiving it.Your platelet count is at least 100 billion per liter.Your hemoglobin level is at least 90 grams per liter.Your bilirubin levels are not higher than 1.5 times the normal limit.I haven't taken drugs targeting EGFR or ALK, nor have I had immune therapy or viral cancer treatments.I can and will complete the quality of life surveys.I am using effective birth control and will continue for 6 months after my last treatment.I am not currently taking any experimental drugs or cancer treatments.I am 18 years old or older.I haven't had chemotherapy for advanced cancer.My lung cancer is confirmed and not caused by EGFR mutations or ALK-fusion.I completed my chemotherapy and radiation for Stage III cancer over a year ago.My cancer can be measured and was checked within the last month.My kidney function is within the normal range.Your immune system has enough neutrophils (a type of white blood cell).I have recovered from the side effects of my last radiation treatment.I had surgery, it's healed, and it's been over 14 days since.I have heart problems that are not being treated or controlled.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab and Tremelimumab
- Group 2: Platinum based chemotherapy + Durvalumab + Tremelimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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