Recruiting
Phase 3
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition(s) studied
Metastatic Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
Dato-DXdOsimertinibPemetrexedCarboplatinCisplatin
Dato-DXd: Dato-DXd will be administered as IV infusion.
Osimertinib: Osimertinib will be administered orally.
Pemetrexed: Pemetrexed will be administered as IV infusion.
Carboplatin: Carboplatin will be administered as IV infusion.
Cisplatin: Cisplatin will be administered as IV infusion.
Study summary
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
Eligibility
Inclusion Criteria:
* Histologically or cytologically confirmed non-squamous NSCLC.
* Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M).
* Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
* Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
* At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow reserve and organ function within 7 days before randomization.
Exclusion Criteria:
* Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
* History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
* Unstable spinal cord compression and/or unstable brain metastases.
* Participants with symptomatic brain metastases (including leptomeningeal involvement).
* Clinically significant corneal disease.
* Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Primary outcome measure(s)
- Progression free Survival (PFS) — Up to 2.5 years
PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.
Trial sites (303)
| Facility | City | Region | Status |
| Research Site |
Fayetteville |
Arkansas |
Recruiting |
| Research Site |
Duarte |
California |
Withdrawn |
| Research Site |
Fountain Valley |
California |
Recruiting |
| Research Site |
La Jolla |
California |
Recruiting |
| Research Site |
Los Angeles |
California |
Withdrawn |
| Research Site |
San Diego |
California |
Recruiting |
| Research Site |
Colorado Springs |
Colorado |
Recruiting |
| Research Site |
Fort Collins |
Colorado |
Recruiting |
| Research Site |
Washington D.C. |
District of Columbia |
Not Yet Recruiting |
| Research Site |
Gainesville |
Florida |
Withdrawn |
| Research Site |
Jacksonville |
Florida |
Recruiting |
| Research Site |
Athens |
Georgia |
Recruiting |
| Research Site |
Chicago |
Illinois |
Recruiting |
| Research Site |
Evanston |
Illinois |
Recruiting |
| Research Site |
Louisville |
Kentucky |
Recruiting |
| Research Site |
Baltimore |
Maryland |
Recruiting |
| Research Site |
Bethesda |
Maryland |
Recruiting |
| Research Site |
Boston |
Massachusetts |
Withdrawn |
| Research Site |
Boston |
Massachusetts |
Recruiting |
| Research Site |
Detroit |
Michigan |
Recruiting |
| Research Site |
Kansas City |
Missouri |
Recruiting |
| Research Site |
Omaha |
Nebraska |
Recruiting |
| Research Site |
Morristown |
New Jersey |
Recruiting |
| Research Site |
Northfield |
New Jersey |
Recruiting |
| Research Site |
New York |
New York |
Withdrawn |
| Research Site |
New York |
New York |
Recruiting |
| Research Site |
The Bronx |
New York |
Recruiting |
| Research Site |
Maumee |
Ohio |
Recruiting |
| Research Site |
Philadelphia |
Pennsylvania |
Withdrawn |
| Research Site |
Pittsburgh |
Pennsylvania |
Recruiting |
| Research Site |
Chattanooga |
Tennessee |
Recruiting |
| Research Site |
Nashville |
Tennessee |
Recruiting |
| Research Site |
Fairfax |
Virginia |
Recruiting |
| Research Site |
Seattle |
Washington |
Withdrawn |
| Research Site |
Fitzroy |
Australia |
Recruiting |
| Research Site |
Heidelberg |
Australia |
Recruiting |
| Research Site |
Kogarah |
Australia |
Recruiting |
| Research Site |
Liverpool |
Australia |
Recruiting |
| Research Site |
Nedlands |
Australia |
Recruiting |
| Research Site |
Port Macquarie |
Australia |
Recruiting |
+ 263 more sites — see the full list on the official registry below.