Ceralasertib + Durvalumab for Non-Small Cell Lung Cancer

Recruiting at 22 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must be taking: Chemo-immunotherapy

Must not be taking: Steroids, Live vaccines

Disqualifiers: EGFR/ALK mutations, ILD, 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: 12

Duration: 48 weeks

630 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.

Who Is on the Research Team?

Dwight H Owen

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

This trial is for patients with stage II to select stage IIIB non-small cell lung cancer who've finished at least 3 cycles of chemo-immunotherapy and surgery within the last 4-12 weeks. They must not have a complete response to treatment post-surgery, as those are directed to another study.

Inclusion Criteria

I had surgery for my condition and can start treatment within 4-12 weeks after.

I did not achieve complete tumor removal with surgery.

I completed surgery with no cancer left after chemo-immunotherapy for certain stages of lung cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive durvalumab and/or AZD6738 following surgery. Treatment cycles repeat every 28 days for 12 cycles.

48 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 12 weeks for 2 years, then every 24 weeks until year 5, and annually until 10 years from randomization.

10 years

What Are the Treatments Tested in This Trial?

Interventions

• AZD6738 (Ceralasertib)
• Durvalumab

Trial Overview The trial tests adding AZD6738 (Ceralasertib) to durvalumab immunotherapy versus using durvalumab alone after chemotherapy and surgery. The goal is to see if this combination can extend the time patients remain free from cancer.

How Is the Trial Designed?

Group I: Arm B (Durvalumab and AZD6738) Experimental Treatment 5 Interventions

Starting 4-12 weeks after surgery, patients receive AZD6738 PO BID on days 1-7 and durvalumab IV over 60 minutes on day 8 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated.

Group II: Arm A (Durvalumab) Active Control 4 Interventions

Starting 4-12 weeks after surgery, patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and blood sample collection throughout the study and may undergo echocardiography as clinically indicated.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+