Rak płuca: badanie fazy III leku ivonescimab i pembrolizumab

Kryteria wyłączenia kto nie może wziąć udziału (11)

1. Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
2. Has received any prior therapy for NSCLC in the metastatic setting.
3. Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
4. Known actionable genomic alterations for which first-line approved therapies are indicated
5. Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
6. Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
7. Active autoimmune or lung disease requiring systemic therapy
8. Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
9. Severe infection within 4 weeks prior to randomization
10. Major surgical procedures or serious trauma within 4 weeks prior to randomization
11. History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease