Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)
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
TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: \- Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC: * Participants must have documented negative test results for EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations. Note: If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo prospective testing performed centrally for these genomic alterations in a Sponsor-designated central laboratory. * Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2. Additionally, participants must not have known tumour genomic alteration of any other actionable driver oncogenes for which there are locally approved targeted first-line therapies. Note: Participants whose tumours harbour BRAF (exception V600) or KRAS (exception G12C) mutations are eligible for the study. * Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor- designated, regulatory compliant central laboratory. * Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC. * Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy. * Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2. * At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Adequate bone marrow reserve and organ function within 7 days before randomisation. Exclusion Criteria: * Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology. * NSCLC disease that is eligible for definitive local therapy alone. * History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence. * Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation. * Clinically significant corneal disease. * Has active or uncontrolled hepatitis B or C virus infection. * Known human immunodeficiency virus (HIV) infection that is not well controlled. * Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals. * History of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE), and any radiographic features consistent with interstitial lung abnormalities, including but not limited to, extensive ground glass opacities, reticular opacities, traction bronchiectasis, and honeycombing. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrolment, severe asthma, severe COPD, restrictive lung disease, symptomatic pleural effusion, etc).
Study sites (51)
AZ
- Research Site · Chandler, AZ 85224More trials in Chandler
- Research Site · Gilbert, AZ 85234More trials in Gilbert
- Research Site · Goodyear, AZ 85338More trials in Goodyear
CA
- Research Site · Duarte, CA 91010More trials in Duarte
- Research Site · Irvine, CA 92618More trials in Irvine
- Research Site · La Jolla, CA 92093More trials in La Jolla
- Research Site · Loma Linda, CA 92350More trials in Loma Linda
- Research Site · Los Angeles, CA 90095More trials in Los Angeles
- Research Site · San Diego, CA 92123More trials in San Diego
CO
- Research Site · Grand Junction, CO 81501More trials in Grand Junction
- Research Site · Wheat Ridge, CO 80033More trials in Wheat Ridge
DC
- Research Site · Washington D.C., DC 20037More trials in Washington D.C.
DE
- Research Site · Newark, DE 19713More trials in Newark
FL
- Research Site · Fort Myers, FL 33901More trials in Fort Myers
- Research Site · Jacksonville, FL 32224More trials in Jacksonville
- Research Site · St. Petersburg, FL 33709More trials in St. Petersburg
- Research Site · Tampa, FL 33612More trials in Tampa
- Research Site · West Palm Beach, FL 33401More trials in West Palm Beach
GA
- Research Site · Marietta, GA 30060More trials in Marietta
- Research Site · Newnan, GA 30265More trials in Newnan
IL
- Research Site · Chicago, IL 60612More trials in Chicago
- Research Site · Chicago, IL 60637More trials in Chicago
- Research Site · Hinsdale, IL 60521More trials in Hinsdale
- Research Site · Niles, IL 60714More trials in Niles
- Research Site · Zion, IL 60099More trials in Zion
KY
- Research Site · Louisville, KY 40207More trials in Louisville
MA
- Research Site · Boston, MA 02215More trials in Boston
MD
- Research Site · Baltimore, MD 21201More trials in Baltimore
- Research Site · Brandywine, MD 20613More trials in Brandywine
ME
- Research Site · South Portland, ME 04106More trials in South Portland
MI
- Research Site · Detroit, MI 48202More trials in Detroit
MN
- Research Site · Rochester, MN 55905More trials in Rochester
MO
- Research Site · Bridgeton, MO 63044More trials in Bridgeton
- Research Site · Columbia, MO 65212More trials in Columbia
NE
- Research Site · Lincoln, NE 68516More trials in Lincoln
NM
- Research Site · Albuquerque, NM 87109More trials in Albuquerque
NY
- Research Site · East Syracuse, NY 13057More trials in East Syracuse
OR
- Research Site · Portland, OR 97239More trials in Portland
PA
- Research Site · Hershey, PA 17033More trials in Hershey
- Research Site · Lancaster, PA 17601More trials in Lancaster
SC
- Research Site · Greenville, SC 29607More trials in Greenville
TN
- Research Site · Memphis, TN 38120More trials in Memphis
TX
- Research Site · Austin, TX 78745More trials in Austin
- Research Site · Denton, TX 76201More trials in Denton
- Research Site · Plano, TX 75075More trials in Plano
VA
- Research Site · Charlottesville, VA 22908More trials in Charlottesville
- Research Site · Fairfax, VA 22031More trials in Fairfax
- Research Site · Williamsburg, VA 23188More trials in Williamsburg
WA
- Research Site · Tacoma, WA 98405More trials in Tacoma
WI
- Research Site · Eau Claire, WI 54703More trials in Eau Claire
WV
- Research Site · Morgantown, WV 26506More trials in Morgantown