What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and antibody-drug conjugates like Datopotamab Deruxtecan. Chemotherapy often leads to side effects such as neutropenia, anemia, thrombocytopenia, nausea, vomiting, and alopecia. Immunotherapy, including agents like pembrolizumab and durvalumab, can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Specific to antibody-drug conjugates, side effects may include myelosuppression (neutropenia, anemia, thrombocytopenia), interstitial lung disease, and gastrointestinal symptoms like nausea and diarrhea.

What prior FDA approvals exist?

The FDA has approved several targeted therapies and antibody-drug conjugates (ADCs) for the treatment of Non-Small Cell Lung Cancer (NSCLC). Fam-trastuzumab deruxtecan, an ADC targeting HER2, is approved for patients with HER2-mutant NSCLC who have progressed on prior therapy. Ado-trastuzumab emtansine is another ADC approved for HER2-positive cancers. Additionally, immunotherapy agents such as pembrolizumab and atezolizumab, often combined with chemotherapy, have been approved for various subsets of NSCLC, including those without actionable genomic alterations. These treatments aim to improve progression-free survival and overall survival in patients with advanced NSCLC.

What other types of research exist?

Promising alternatives to Datopotamab Deruxtecan for NSCLC patients include Trastuzumab Deruxtecan, which has shown efficacy in HER2-positive breast cancer and is being explored for other cancers, and Sacituzumab Govitecan, which targets Trop-2 and has been approved for metastatic triple-negative breast cancer. Additionally, combination therapies involving immune checkpoint inhibitors like pembrolizumab with histology-specific platinum-based chemotherapy are also being investigated for their potential in treating advanced NSCLC.

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Chemotherapy

Dato-DXd + Durvalumab + Carboplatin for Advanced Non-Small Cell Lung Cancer (AVANZAR Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions at the infusion site, fatigue, nausea, low blood counts leading to increased infection risk or bleeding problems, potential lung issues like pneumonitis, and other organ inflammations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS) in the TROP2 biomarker positive population

Progression-Free Survival (PFS) in the TROP2 biomarker positive population

Secondary study objectives

Anti-Drug Antibody (ADA) for Dato-DXd

Clinical Outcome Assessments such as TTD in pulmonary symptoms (dyspnoea, cough and chest pain) as measured by the NSCLC-SAQ, and TTD in physical functioning as measured by PROMIS Physical Function short form 8c

Duration of Response (DoR) in the TROP2 biomarker positive and ITT populations

+8 more

Other study objectives

Safety of Dato-DXd in combination with durvalumab and carboplatin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dato-DXd + Durvalumab + CarboplatinExperimental Treatment3 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 therapyActive Control5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Carboplatin

2014

Completed Phase 3

~6120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include antibody-drug conjugates (ADCs) like Datopotamab Deruxtecan, which target specific proteins on cancer cells to deliver cytotoxic drugs directly, minimizing harm to healthy cells. Immune checkpoint inhibitors, such as anti-PD-1 and anti-PD-L1 therapies, enhance the immune system's ability to attack cancer by blocking proteins that inhibit immune response. These targeted therapies are significant for NSCLC patients as they offer more effective and less toxic treatment options compared to traditional chemotherapy, potentially improving survival rates and quality of life.