A study of SGN-B6A versus docetaxel in previously treated non-small cell lung cancer
- Conditions
- on-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503827-25-01
- Lead Sponsor
- Seagen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 567
Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic (Stage IV: M1a, M1b, or M1c) NSCLC per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition)., Subjects must have NSCLC with nonsquamous histology: oTumors with squamous, or predominantly squamous histology are excluded. oTumors with small cell elements are excluded, Subjects who have NSCLC with known AGAs are permitted (eg, EGFR mutations, ALK translocations)., Subjects must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy: • Subjects with no known AGAs must fulfill 1 of the following conditions: oReceived a platinum based combination therapy for the treatment of metastatic or recurrent disease and a PD (L)1 monoclonal antibody (concurrently or sequentially with platinum based chemotherapy), unless contraindicated. oExperienced disease progression within 6 months of the last dose of platinum based chemotherapy in the adjuvant or neoadjuvant setting for early or locally advanced stage disease and received an anti-PD-(L)1 monoclonal antibody at any time during the course of treatment. • Subjects with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions: oMust have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the subject. oMust have received prior treatment with only 1 platinum-based chemotherapy regimen. This includes subjects who have experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the neoadjuvant and/or adjuvant setting for early or locally advanced-stage disease, oMay have received up to 1 anti-PD (L)1 monoclonal antibody (concurrently or sequentially with platinum based chemotherapy).
Prior therapy: • Prior treatment with anti-microtubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable, or metastatic setting. •Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable, or metastatic setting. • At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1. Subjects must have recovered from all radiation-related toxicities that would otherwise prevent trial participation. Palliative radiotherapy within the 14 days prior to Cycle 1 Day 1 may be allowed upon discussion with the sponsor’s medical monitor or their designee. • Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1. • Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1. • Subjects with Grade =2 ongoing toxicities associated with prior therapies will be excluded, with the exception of alopecia, Pre-existing peripheral neuropathy Grade =2 per NCI CTCAE v5.0., Uncontrolled diabetes mellitus, defined as HbA1c =8.0% or HbA1c between 7% and <8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained., Subjects with any of the following respiratory conditions: • Evidence of noninfectious ILD or pneumonitis that: o Was previously diagnosed and required systemic steroids, or o Is currently diagnosed and managed, or o Is suspected on radiologic imaging at screening • Known DLCO (adjusted for hemoglobin) <50% predicted • Any Grade =3 pulmonary disease unrelated to underlying malignancy including, but not limited to: o Pulmonary emboli within 3 months of Cycle 1 Day 1 o Severe asthma requiring systemic corticosteroids within 30 days prior to Cycle 1 Day 1 or is not well controlled with low-dose inhaled corticosteroids/long-acting beta-2 agonists o Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids o Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method