Clinical trial · Interventional
A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]
A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)
NCT01714037CI-TRIAL-00017437HALOterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Debio 0932 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cisplatin, Pemetrexed, Debio 0932
- description
- Cisplatin, Pemetrexed, Debio 0932
- interventionNames
- Drug: Debio 0932
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- EXPERIMENTAL
- label
- Cisplatin, Gemcitabine, Debio 0932
- description
- Cisplatin, Gemcitabine, Debio 0932
- interventionNames
- Drug: Debio 0932
- Drug: Cisplatin
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Docetaxel, Debio 0932
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation * Advanced or metastatic disease (Stage IIIb or IV) * Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if \> 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy * Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * ECOG performance score 0-1 * Life expectancy ≥ 3 months * Adequate bone marrow-, renal- and hepatic function * LVEF ≥ 55% on cardiac ultrasound Exclusion Criteria: * Symptomatic brain metastases * Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease) * Concurrent treatment with any other systemic anti-cancer therapy * Serious concomitant uncontrolled medical conditions
References
Publications (0)
Data not yet available
No reference posted for this study.