Durvalumab + Chemotherapy for Lung Cancer
(AEGEAN Trial)

Recruiting in Palo Alto (17 mi)

+199 other locations

Overseen byJohn V. Heymach, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Eligibility Criteria

Adults over 18 with newly diagnosed, untreated non-small cell lung cancer that can be surgically removed may join. They should have good physical function and no prior immune therapy or certain other cancers. Surgery must be planned (lobectomy, sleeve resection, bilobectomy) and they cannot have brain metastases, active infections like TB or HIV, a history of organ transplant, or autoimmune diseases.

Inclusion Criteria

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

I have at least one cancer spot that can be measured and hasn't been treated with radiation.

I have not had treatments like immunotherapy for my condition.

+6 more

Exclusion Criteria

Known allergy or hypersensitivity to any of the study drugs or excipients

I do not have active infections like TB, hepatitis B or C, or HIV.

My cancer has a confirmed EGFR mutation or ALK translocation.

+10 more

Participant Groups

The trial is testing Durvalumab combined with chemotherapy before surgery against a placebo plus chemotherapy to see if it leads to complete removal of the tumor. It's randomized and double-blind meaning neither doctors nor patients know who gets the real drug versus placebo.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: Durvalumab with platinum-based chemotherapyExperimental Treatment7 Interventions

Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)

Group II: Arm 2: Placebo with platinum-based chemotherapyPlacebo Group7 Interventions

Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: