Non-small Cell Lung Cancer study: Datopotamab deruxtecan vs Docetaxel
Official title Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
ClinicalTrials.gov ID: NCT07291037
What this study is testing
What is Datopotamab deruxtecan (Dato-DXd)?
an investigational IV medicine being studied as a potential treatment for advanced or metastatic non‑small cell lung cancer that is TROP2‑positive and lacks actionable genomic alterations. is designed to bind the TROP2 protein on cancer cells and deliver a chemotherapy payload (deruxtecan) that interferes with DNA replication.
Also referred to as DS-1062a.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out how effective and safe datopotamab deruxtecan is compared with docetaxel in this patient group.
- Who it's for
- Adults with advanced or metastatic non‑small cell lung cancer that is TROP2‑positive and lacks actionable genomic alterations, who have already received treatment.
- What's involved
- Participants will be randomly assigned to receive either datopotamab deruxtecan or docetaxel, with regular clinic visits for the medication and safety tests.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2.
- Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor-...
- 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...
You likely can't join if
- 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...
- Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at...
- Clinically significant corneal disease.
- Has active or uncontrolled hepatitis B or C virus infection.
See the full eligibility criteria
- 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.
- Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2.
- 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...
- 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Adequate bone marrow reserve and organ function within 7 days before randomisation.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Goodyear, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Grand Junction, Colorado, United States
- Wheat Ridge, Colorado, United States
- Newark, Delaware, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Marietta, Georgia, United States
- Newnan, Georgia, United States
- Chicago, Illinois, United States
+ 142 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Gilbert, Arizona, United States; Goodyear, Arizona, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States and 156 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.