Dato-DXd + Durvalumab + Carboplatin for Advanced Non-Small Cell Lung Cancer

(AVANZAR Trial)

Recruiting in Palo Alto (17 mi)

+245 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug combination for adults with advanced NSCLC without specific genetic mutations. The treatment includes Dato-DXd, durvalumab, and carboplatin, which work together to kill cancer cells, boost the immune system, and stop cancer cell growth.

Research Team

Charu Aggarwal

Principal Investigator

Perelman Center for Advanced Medicine

Eligibility Criteria

Adults over 18 with advanced non-small cell lung cancer (NSCLC) stages IIIB, IIIC, or IV without certain genetic changes can join. They should be in good physical condition (ECOG PS of 0 or 1), have not had previous systemic therapy for their cancer stage, and must have proper organ function and bone marrow reserve.

Inclusion Criteria

My lung cancer is at an advanced stage and cannot be removed by surgery.

My cancer does not have certain genetic changes that can be treated with specific drugs.

I am 18 years old or older.

Exclusion Criteria

My lung cancer is a mix of small-cell and non-small cell or is a sarcomatoid variant.

I have a serious eye condition affecting my cornea.

I still have side effects from cancer treatment that haven't improved.

Treatment Details

Interventions

• Carboplatin (Chemotherapy)
• Datopotamab deruxtecan (Antibody-drug conjugate)
• Durvalumab (Checkpoint Inhibitor)

Trial Overview The trial is testing a new combination of drugs: Datopotamab Deruxtecan (Dato-DXd) with Durvalumab and Carboplatin against the standard treatment Pembrolizumab with platinum-based chemotherapy. It's to see which is better as a first-line treatment for NSCLC.

Participant Groups

Group I: Dato-DXd + Durvalumab + Carboplatin Experimental Treatment 3 Interventions

Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve \[AUC\] 5 mg/mL/minute.

Group II: Histologic-specific therapy Active Control 5 Interventions

Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

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