Clinical trial · Interventional
Soblidotin in Treating Patients With Progressive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase II Study Of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, To Patients With Progressive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NSCLC) Following Treatment With Platinum-Based 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)
RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have progressive locally advanced or metastatic non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| soblidotin | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Locally advanced or metastatic disease * Demonstrates tumor progression * Must have received 1 prior chemotherapy regimen * Prior chemotherapy must have included a platinum agent * Measurable disease * At least 1 measurable lesion outside the field of any prior radiotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 times ULN Cardiac * Ejection fraction at least 40% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric disorder that would preclude giving informed consent or following study instruction * No grade 2 or greater neurotoxicity * No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years prior to study entry * No other concurrent severe or uncontrolled underlying medical disease that would compromise patient safety and study outcome * No concurrent serious infection PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biologic therapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No concurrent anticancer radiotherapy * Concurrent localized radiotherapy to a non-indicator lesion for pain relief is allowed provided other methods of pain control are ineffective Surgery * At least 4 weeks since prior major surgery and recovered Other * At least 4 weeks since prior myelosuppressive therapy * More than 28 days since prior investigational drugs * No other concurrent investigational drugs * No other concurrent anticancer cytotoxic therapy
References
Publications (0)
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