RecruitingPhase 1

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

A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of trastuzumab deruxtecan (T-DXd) with drugs that help the immune system fight cancer, with or without chemotherapy. It is for people with advanced or spreading non-squamous non-small cell lung cancer that makes too much HER2 protein. The study will also check how well the treatment works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-squamous non-small cell lung cancer confirmed by a tissue test. The cancer cannot be removed by surgery and has grown nearby or spread.
  • A study lab must confirm that the tumor makes too much HER2 protein.
  • Be fully active or able to do light work, and have cancer that can be measured on scans.
  • Have organs and bone marrow that work well enough for the study.
  • Part 1: The cancer must have worsened after 1 or 2 rounds of treatment plans for cancer that returned or spread.
  • Parts 3–5: The tumor must not have known gene changes that have approved targeted treatments.
  • Parts 3–5: Have had no treatment for advanced or spreading lung cancer. Certain earlier chemotherapy or chemotherapy with radiation is allowed if the cancer worsened more than 6 months after treatment ended.
  • Parts 3–5: Weigh at least 35 kg (about 77 pounds).

Who can't join

  • A known HER2 gene change; current or suspected lung inflammation not caused by infection; past lung inflammation needing steroids; other serious lung illness; or past removal of a whole lung.
  • An immune system disorder present from birth, known HIV, or current or past hepatitis B. Hepatitis C antibodies are allowed only if testing finds no active virus. Active infections, including tuberculosis, or uncontrolled infections needing medicines through a vein also exclude you.
  • Pressure on the spinal cord, or cancer in the brain or spinal cord that is untreated and causing symptoms, or needs steroids or seizure drugs to control symptoms.
  • Certain serious heart problems, or a heart attack or stroke within 6 months. Parts 3–5 have added heart limits, including heart muscle disease, unstable chest pain, abnormal heart rhythms, or a heart attack within 12 months.
  • Fluid in the belly or around the heart that needs drainage, a tube to drain belly fluid, or treatment that filters and returns belly fluid.
  • Side effects from past cancer treatment that have not become mild or returned to their earlier level; having stopped a planned study drug because of side effects; or being unable to safely receive platinum chemotherapy.
  • Parts 3–5: Skin disease not caused by infection that needs whole-body treatment, or an immune or inflammatory disease needing long-term steroids or other drugs that weaken the immune system. Prior treatment with certain immune cancer drugs or any experimental immune therapy also excludes you.
  • Parts 3–5: A history of substance abuse or other health conditions that could affect study participation or results; or blood clots in the lungs, deep veins, or veins draining the brain within 3 months before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: * Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC * Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. * Part 3, Part 4 and Part 5: Patients must have tumors that do not harbor known genomic alterations or actionable driver kinases, for which approved therapies are available are allowed. * Part 3, Part 4 and Part 5: Patient must be treatment-naïve for advanced or metastatic NSCLC. Patients who have received prior adjuvant, or neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred \> 6 months from end of last therapy * HER2overexpression status as determined by central review of tumor tissue * WHO / ECOG performance status of 0 or 1 * Measurable target disease assessed by the investigator using RECIST 1.1 * Has protocol defined adequate organ and bone marrow function * Part 3, Part 4 and Part 5: Minimum body weight of 35 kg. Exclusion criteria: * HER2 mutation if previously known * 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 * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy * Active primary immunodeficiency known HIV infection, or active chronic and resolved hepatitis B (positive hepatitis B virus surface antigen \[HBsAg+ve\] or hepatitis B virus core antibody (anti-HBc +ve) regardless of HBV DNA level)) or hepatitis C infection. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to treatment assignment if required by local regulations or IRB/EC * Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals * Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms * Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (\< 6 months) cardiovascular event including stroke * For Part 3, Part 4 and Part 5: Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class \> II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia are to be excluded. Patients with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before treatment assignment to rule out acute cardiopulmonary events. * Ascites or pericardial effusion that requires drainage, peritoneal shunt, Pleuroperitoneal shunt or CART (Concentrated Ascites Reinfusion Therapy) * For Part 3, Part 4 and Part 5: Active non-infectious skin disease (including any grade rash, urticarial, dermatitis, ulceration, or psoriasis) requiring systemic treatment, active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. * Unresolved toxicities not yet resolved to Grade ≤ 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity. * must not have any medical contraindication to platinum-based chemotherapy. * Part 3, Part 4 and Part 5 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting. * For Part 3, Part 4 and Part 5: History of substance abuse or any other medical or psychological conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results * For Part 3, Part 4 and Part 5: History of thromboembolic events within 3 months before the first dose of IP (limited to pulmonary embolism, deep vein thrombosis, or cerebral venous sinus thrombosis).

Study sites (13)

CA

KS

MD

MI

NY

TX

VA

WA