Durvalumab vs Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 74 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must not be taking: Steroids, Immunotherapy

Disqualifiers: Brain metastases, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: 12 months

669 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing durvalumab, an immunotherapy drug, in patients with advanced lung cancer who do not have certain genetic mutations and have high levels of a specific protein. The drug helps the immune system see and fight the cancer better.

Research Team

Shire Norah

Principal Investigator

AstraZeneca GMD IO, Gaitherburg, MD, USA

Parker Suzanne

Principal Investigator

AstraZeneca RDM, South San Francisco, USA

Eligibility Criteria

This trial is for adults with Stage IV Non-Small Cell Lung Cancer (NSCLC) who have not had prior treatment, do not have certain gene mutations (EGFR/ALK), and show high PD-L1 expression. It's not for those with a history of significant autoimmune diseases, untreated brain metastases, or previous immune therapy.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer shows high PD-L1 expression.

My condition is Stage IV non-small cell lung cancer.

Exclusion Criteria

I have stable brain or spinal metastases and haven't taken steroids for 14 days.

I have or had an autoimmune or inflammatory disorder like colitis.

I have not had chemotherapy or any systemic therapy for advanced NSCLC.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Durvalumab or standard of care platinum-based chemotherapy

12 months

Tumor assessments every 6 weeks for the first 48 weeks, then every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

57 months

Long-term Follow-up

Participants are assessed for overall survival and progression-free survival

Up to 69 months

Treatment Details

Interventions

• Durvalumab (MEDI4736)
• Gemcitabine + carboplatin
• Gemcitabine + cisplatin
• Paclitaxel + carboplatin
• Pemetrexed + carboplatin
• Pemetrexed + cisplatin

Trial Overview The study compares the effectiveness and safety of Durvalumab alone versus various combinations of chemotherapy drugs in first-line treatment. Patients are randomly assigned to receive either Durvalumab or one of several standard chemo options.

Participant Groups

Group I: Arm 1: Durvalumab Experimental Treatment 1 Intervention

Anti-PD-L1 monoclonal Antibody monotherapy

Group II: Arm 2: Standard of Care Active Control 5 Interventions

Standard of Care Platinum-Based chemotherapy

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology