Clinical trial · Interventional
KD019 Versus Erlotinib in Subjects With Stage IIIB/IV Non Small Cell Lung Cancer With Progression After First- or Second-Line Chemotherapy
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
Summary
Brief summary (as posted)
This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erlotinib | Drug | Erlotinib | ALIAS |
| KD019 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KD019
- description
- KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
- interventionNames
- Drug: KD019
- type
- ACTIVE_COMPARATOR
- label
- Erlotinib
- description
- Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
- interventionNames
- Drug: Erlotinib
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For Eligibility subjects must have: * failed one or two previous courses of therapy. * have no active brain metastasis. Treated non-active brain metastasis are acceptable. * cannot have received an Epidermal Growth Factor Receptors inhibitor (Tarceva \[erlotinib\] or Iressa \[gefitinib\]) in the past. * has demonstrated progressive disease.
References
Publications (0)
Data not yet available