Clinical trial · Interventional
Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy
Single-Arm, Open-label, Multicenter, Phase 2 Clinical Trial to Assess the Efficacy and Safety of Single-Agent Camtobell Inj.(Belotecan) Administered on A Weekly Schedule in Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients Previously Treated With Chemotherapy
- 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)
A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Belotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Belotecan
- description
- Single arm
- interventionNames
- Drug: Belotecan
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- every 2 cyc
Secondary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 6 months after Last patient out
- measure
- Progression Free survival
- timeFrame
- 6 months after Last patient out
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 19 Years and older * Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV) * ≥ one measureable or evaluable lesion, \<25% of the bone marrow had been irradiated * prior platinum based chemotherapy * ECOG PS ≤ 2 * Life expectancy \> 3 months * Adequate organ function: * hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL * hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN * renal: serum creatinine ≤ 1.5×ULN * Signed a written informed consent Exclusion Criteria: * Active infection * Symptomatic brain lesion * Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix * Severe concurrent diseases * Prior anticancer therapy within 4 weeks before enroll * Active pregnancy test
References
Publications (0)
Data not yet available