Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Conditions

• Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• T-DXd — DRUG
  T-DXd: administered as an IV infusion
• Durvalumab — BIOLOGICAL
  Durvalumab: administered as an IV infusion
• Cisplatin — DRUG
  Cisplatin: administered as an IV infusion
• Carboplatin — DRUG
  Carboplatin: administered as an IV infusion
• Pemetrexed — DRUG
  Pemetrexed: administered as an IV infusion (drug not used)
• Volrustomig — DRUG
  Volrustomig: administered as an IV infusion
• Rilvegostomig — DRUG
  Rilvegostomig: administered as an IV infusion

Study Details

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Key Dates

Start date

Mar 9, 2021

Status verified

Feb 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

304 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1A: T-DXd, Durvalumab and Cisplatin
  T-DXd, Durvalumab and Cisplatin
• Experimental: Arm 1B: T-DXd, Durvalumab and Carboplatin
  T-DXd, Durvalumab and Carboplatin
• Experimental: Arm 1C: T-DXd, Durvalumab and Pemetrexed
  T-DXd, Durvalumab and Pemetrexed (Arm not initiated)
• Experimental: Arm 1D: T-DXd
  T-DXd
• Experimental: Arm 3A: T-DXd and Volrustomig
  Drug: T-DXd and Volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig
• Experimental: Arm 3B: T-DXd, Volrustomig and Carboplatin
  Drug: T-DXd, Volrustomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig Drug: Carboplatin Carboplatin: administered as an IV infusion
• Experimental: Arm 4A: T-DXd and Rilvegostomig
  T-DXd and Rilvegostomig Drug: T-DXd, Rilvegostomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936
• Experimental: Arm 4B T-DXd and Rilvegostomig with Carboplatin
  Drug: T-DXd, Rilvegostomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936 Drug: Carboplatin Carboplatin: administered as an IV infusion
• Experimental: Arm 5A: T-DXd and Volrustomig
  Drug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (priming dose in first cycle, fixed dose in subsequent cycles) Other Name: volrustomig
• Experimental: Arm 5B: T-DXd and Volrustomig
  Drug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (fixed dose from first cycle onward) Other Name: volrustomig

Primary Outcome Measure

Frequency of AEs and SAEs [ Time Frame: Safety and tolerability (and to determine RP2D) will be assessed for approximately 20 months from informed consent ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]
• AstraZeneca Lung Cancer Study Locator Service
  1-884-432-3892
  [email protected]

Locations (13)

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