RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Trastuzumab Deruxtecan for Non-small Cell Lung Cancer

This clinical trial is designed to assess the how well it works and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Official registry: https://clinicaltrials.gov/study/NCT06899126 · Daiichi Sankyo · enrollment listed as 686

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab Deruxtecan, pembrolizumab, or Pemetrexed. The registry lists allocation as randomized. This clinical trial is designed to assess the how well it works and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

They plan to enroll about 686 people at 246 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

Interventions: Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed, Platinum Chemotherapy

Primary outcome (registry wording): Progression Free Survival by Blinded Independent Central Review

Who it is for (from inclusion criteria)

Ages 18 Years to any
Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures
Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable
Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old
Histologically documented non-squamous locally advanced unresectable or metastatic
NSCLC and meets all of the following criteria:
Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
HER2-targeted antibody-based anticancer therapy

Who the registry excludes

Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:
Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion)
Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis)
Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen
Had a prior complete pneumonectomy

Public study contact (from the registry)

Contact for Trial Information

908-992-6400

CTRinfo_us@daiichisankyo.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

246 listed

Alaska Oncology & Hematology, LLC — Anchorage, Alaska (recruiting)
Orange Coast Memorial Medical Center Fountain Valley — Fountain Valley, California (recruiting)
California Research Institute — Los Angeles, California (recruiting)
Los Angeles Cancer Network (LACN) — Los Angeles, California (recruiting)
Providence Medical Foundation — Santa Rosa, California (recruiting)
Bay Pines VA Healthcare System — Bay Pines, Florida (recruiting)
Lynn Cancer Institute Center — Boca Raton, Florida (recruiting)
Holy Cross Hospital — Fort Lauderdale, Florida (recruiting)
Mid-Florida Hematology & Oncology Centers, P.A. — Orange City, Florida (recruiting)
BRCR Global Plantation — Plantation, Florida (recruiting)
Cleveland Clinic Florida - Weston — Weston, Florida (recruiting)
Piedmont Cancer Institute OneOncology — Atlanta, Georgia (recruiting)

+ 220 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06899126 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06899126?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06899126?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary