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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
ECOG performance status of 0 or 1.
AST and ALT ≤ 2.5 x UNL (if liver metastases are present, ≤5 x UNL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver function tests are within the required range.
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I finished my adjuvant therapy for fully removed cancer over a year ago.
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My cancer is at stage IV.
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My cancer has grown in areas not previously treated with radiation.
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I had radiation therapy, but it ended at least 2 weeks ago and I'm not currently receiving it.
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I haven't taken drugs targeting EGFR or ALK, nor have I had immune therapy or viral cancer treatments.
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I can and will complete the quality of life surveys.
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I am 18 years old or older.
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I haven't had chemotherapy for advanced cancer.
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My lung cancer is confirmed and not caused by EGFR mutations or ALK-fusion.
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I completed my chemotherapy and radiation for Stage III cancer over a year ago.
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My cancer can be measured and was checked within the last month.
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My kidney function is within the normal range.
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I am using effective birth control and will continue for 6 months after my last treatment.
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I have recovered from the side effects of my last radiation treatment.
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I had surgery, it's healed, and it's been over 14 days since.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Objective Response Rate Using RECIST 1.1 and iRECIST
Progression-free Survival Using RECIST 1.1

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?

Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoOTHER
177 Previous Clinical Trials
148,251 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
474,836 Total Patients Enrolled
Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
66,851 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03057106 — Phase 2
Lung Cancer Research Study Groups: Durvalumab and Tremelimumab, Platinum based chemotherapy + Durvalumab + Tremelimumab
Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03057106 — Phase 2
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03057106 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many staff locations are responsible for administering this study?

"This study is being conducted in Sherbrooke, Windsor, Sudbury and 30 other locations across Canada."

Answered by AI

Are we still looking for volunteers for this experiment?

"This particular study is no longer recruiting patients. The listing was created on February 15th, 2017 and last updated on June 23rd, 2022. However, there are 495 studies for Durvalumab and Tremelimumab enrolling patients and 1,543 trials for lung cancer currently underway."

Answered by AI

What are the two drugs most often given together Durvalumab and Tremelimumab?

"Durvalumab and Tremelimumab are the recommended treatment for unresectable stage iii non-small cell lung cancer. They can also be used to treat other conditions like metastatic ureter urothelial carcinoma and advance directives."

Answered by AI

Has the FDA rubber-stamped Durvalumab and Tremelimumab?

"Durvalumab and Tremelimumab have been found to be safe in Phase 2 trials, but there is no evidence yet of the drugs' efficacy."

Answered by AI

Are Durvalumab and Tremelimumab new drugs?

"The initial study for Durvalumab and Tremelimumab took place in 2002 at the Department of Radiation Oncology. 495 clinical trials are still ongoing, with a large portion based out of Sherbrooke, Ontario."

Answered by AI

How many people can join this clinical trial at most?

"This particular lung cancer clinical trial is no longer recruiting patients; however, there are 495 other trials for Durvalumab and Tremelimumab that still need participants. If you're interested in exploring additional studies, 1543 other studies are actively searching for patients with lung cancer."

Answered by AI
~38 spots leftby Mar 2025