Clinical trial · Interventional
Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts. Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant (KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy the progression free survival of patients with KRASm NSCLC will be doubled.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacomitinib | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| PD-0325901 | Drug | Mirdametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dacomitinib + PD-0325901
- description
- Dacomitinib: oral tablets PD-0325901: oral capsules
- interventionNames
- Drug: Dacomitinib
- Drug: PD-0325901
- Drug: Docetaxel
Primary outcomes (2)
- measure
- Incidence rate of dose-limiting toxicities
- timeFrame
- 1.5 years
- measure
- Progression free survival
- timeFrame
- 2.5 years
Secondary outcomes (6)
- measure
- Incidence and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological proof of advanced non-small cell lung cancer * Written documentation of KRAS (exon 2, 3 or 4) mutation * At least 18 years of age or older * Able and willing to give written informed consent * WHO performance status of 0 or 1 Exclusion Criteria: * Symptomatic or untreated leptomeningeal disease * Symptomatic brain metastasis * Impairment of gastrointestinal function * Uncontrolled infectious disease * Left ventricular ejection fraction \< 50% * Retinal degenerative disease or with history of uveitis, retinal vein occlusion or retinal detachment Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDvan Geel RMJM, van Brummelen EMJ, Eskens FALM, Huijberts SCFA, de Vos FYFL, Lolkema MPJK, Devriese LA, Opdam FL, Marchetti S, Steeghs N, Monkhorst K, Thijssen B, Rosing H, Huitema ADR, Beijnen JH, Bernards R, Schellens JHM. Phase 1 study of the pan-HER inhibitor dacomitinib plus the MEK1/2 inhibitor PD-0325901 in patients with KRAS-mutation-positive colorectal, non-small-cell lung and pancreatic cancer. Br J Cancer. 2020 Apr;122(8):1166-1174. doi: 10.1038/s41416-020-0776-z. Epub 2020 Mar 9. PMID 32147669