non-small cell lung cancer
Conditions
Interventions
Sigvotatug vedotin group:Sigvotatug vedotin
Docetaxel group:Docetaxel
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and legally an adult at time of consent, and >= the age of majority per regional requirements; 2. 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); 3. Participants must have NSCLC with nonsquamous histology: (1) Tumors with squamous, or predominantly squamous histology are excluded; (2) Tumors with small cell elements are excluded; 4. Participants who have NSCLC with known AGAs are permitted (eg, EGFR mutations, ALK translocations); 5. Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy: (1) Participants with no known AGAs must fulfill 1 of the following conditions: 1) Received 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; 2) Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment; (2) Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions: 1) Must 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 patient; 6. Measurable disease based on RECIST v1.1, as determined by investigator; 7. An ECOG performance status score of 0 or 1. 8. Adequate organ function as defined by the following baseline laboratory criteria obtained within 7 days prior to study intervention initiation (Cycle 1 Day 1): (1) Absolute neutrophil count >=1500/µL; (2) Platelet count>=100,000/µL; (3) Hemoglobin >=9 g/dL or >=5.6 mmol/L; (4) Serum bilirubin 2.5 x ULN, then AST and ALT must be =45 mL/min/1.73 m^2 using the Modification of Diet in Renal Disease (MDRD) study equation as applicable. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies. 9. Participants of childbearing potential (as defined in Section 10.4) under the following conditions: (1) Must have a negative serum pregnancy test (beta human chorionic gonadotropin [ßhCG] with minimum sensitivity 25 mIU/mL or equivalent quantitative assay) result within 72 hours prior to Cycle 1 Day 1. Participants with false positive result confirming non-pregnancy are eligible for participation; (2) Must agree not to become pregnant during the study and for at least 2 months after the final dose of study intervention; (3) Must agree not to breastfeed or donate ova, from the time of informed consent and continuing through at least 2 months
Exclusion criteria
Exclusion criteria: 1. Life expectancy of =90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. 5. Participants with any of the following respiratory conditions: (1) Evidence of noninfectious ILD or pneumonitis that: 1) Was previously diagnosed and required systemic steroids; 2) Is currently diagnosed and managed; 3) Is suspected on radiologic imaging at screening; (2) Known DLCO (adjusted for hemoglobin) =3 pulmonary disease unrelated to underlying malignancy including, but not limited to: 1) Pulmonary emboli within 3 months of Cycle 1 Day 1; 2) 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; 3) Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids; 4) Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc); 6. Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to Cycle 1 Day 1. Participants must have recovered adequately from the toxicity or complications from the surgery prior to starting study intervention. Participants who are planning a major surgery during the treatment period must be excluded from the study. 7. Receipt of a live vaccine within 30 days prior to Cycle 1 Day 1. 8. Pre-existing peripheral neuropathy Grade >=2 per NCI CTCAE v5.0. 9. 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. 10. Prior therapy: (1) Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting. Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible. (2) Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting. Prior cytotoxic chemotherapy in curative settings is permissible. (3) At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1. Participants 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 medi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Progression Free Survival(PFS);Progression Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Objective Response Rate(ORR);Disease control rates(DOR);Describe the safety and tolerability characteristics of Sigvotatug Vedotin; | — |
Countries
China
Contacts
Public ContactWang bin chao
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed