Clinical trial · Interventional
FDG-PET to Investigate SGN-15 and Docetaxel in Patients With Advanced Non-Small Cell Lung Carcinoma
A Phase II Study Using FDG-PET to Investigate the Dosing Schedule and Response of Combination SGN-15 (cBR96-Doxorubicin Immunoconjugate) and Docetaxel in Patients With Stage IV or Stage IIIB Non-Small Cell Lung Carcinoma Ineligible for Combined Modality Treatment With Curative Intent
- 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 an open-label, randomized phase II trial of a monoclonal antibody (mAb) drug immunoconjugate, SGN-15, administered weekly in combination with weekly docetaxel. The primary objective of the study is to determine the optimal interval between SGN-15 and docetaxel using FDG-PET imaging as a surrogate marker of response. In addition, clinical response rate, duration of response, and survival data will be collected.
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-15, Docetaxel | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathologically confirmed stage IIIB or IV NSCLC with a minimum of 1 measurable baseline target lesion who have received no prior chemotherapy for metastatic disease and are not eligible for combined modality therapy with curative intent * Patients must have an ECOG performance status of less than or equal to 2 * -Patients must have a tumor block available for documentation of LeY antigen expression by immunohistochemistry * -FDG-PET imaging must be completed at a PET center approved by Seattle Genetics * Patients must have adequate bone marrow and hepatic function Exclusion Criteria: * -Prior cytotoxic therapy for metastatic NSCLC * -Those with serious underlying non-malignant disease * -Patients with peripheral neuropathy \> Grade 2 are excluded from study * -Patients with IDDM or NIDDM * Patients with known active viral, bacterial, or symptomatic fungal infection * Concomitant with other antineoplastic or experimental agents
References
Publications (0)
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