Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
First-Line Chemotherapy Agents · 1 trial · 2 indications
The percentage of participants with symptomatic NCI CTCAE Grade ≥ 2 CNS hemorrhage, defined as the presence of clinical symptoms determined by the investigator to be directly referable to a Grade ≥ 2 CNS hemorrhage. Grade 1: Asymptomatic, radiographic findings only Grade 2: Medical intervention indicated Grade 3: Ventriculostomy, intracranial pressure (ICP) monitoring, intraventricular thrombolysis, or operative intervention indicated Grade 4: Life-threatening consequences; neurologic deficit or disability Grade 5: Death
| Arm | Type | Description |
|---|---|---|
| bevacizumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| bevacizumab | DRUG | 15 mg/kg intravenously (IV) on the first day of each 21- to 28-day cycle (± 4 days); the interval between infusions could not be \< 17 days, but could extend beyond 28 days if chemotherapy was delayed to allow recovery from toxicity. |
| First-Line Chemotherapy Agents | DRUG | Carboplatin, cisplatin, paclitaxel, docetaxel, gemcitabine, vinorelbine, pemetrexed, or erlotinib administered on Day 1 of every 21-day cycle except gemcitabine, which was administered on Days 1 and 8 of every cycle. Agents were administered as a platinum doublet, or erlotinib alone, at the investigator's discretion. Chemotherapy was administered for a total of 6 planned cycles (up to 8 cycles with prior approval from the Medical Monitor), followed by single-agent bevacizumab therapy. The chemotherapy regimen was to be consistent throughout the study. Erlotinib was administered orally daily. All agents were dosed and administered per institutional standards using the respective package insert as a guideline. |
| Second-Line Chemotherapy Agents | DRUG | Erlotinib, pemetrexed, docetaxel, or chemotherapy at the investigator's discretion. Erlotinib was administered orally daily; pemetrexed and docetaxel were administered IV on Day 1 of every 21-day cycle. Single-agent bevacizumab therapy could be continued at the investigator's discretion if the second-line agent was discontinued. All agents were dosed and administered per institutional standards using the respective package insert as a guideline. |
Inclusion Criteria: * Signed informed consent * Histologically or cytologically confirmed NSCLC except for squamous cell carcinoma * Treated brain metastases without evidence of progression or hemorrhage after treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during th...
Top 20 of 84 competitors
First-Line Chemotherapy Agents is an investigational small molecule being studied for the treatment of non-small cell lung cancer, specifically in patients with treated brain metastases due to non-squamous NSCLC. It is being developed by Roche Holding AG and is currently in Phase 2 clinical development.
First-Line Chemotherapy Agents is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The drug is an investigational small molecule in Phase 2 clinical development for non-small cell lung cancer.
First-Line Chemotherapy Agents is in Phase 2 clinical development. It is an investigational small molecule being studied for non-small cell lung cancer, specifically in patients with treated brain metastases due to non-squamous NSCLC. It is not yet approved and remains in clinical testing.
First-Line Chemotherapy Agents has been studied in one completed Phase 2 clinical trial, NCT00312728, titled 'A Study of Bevacizumab in Combination With First- or Second-Line Therapy in Subjects With Treated Brain Metastases Due to Non-Squamous NSCLC (PASSPORT)'. The trial enrolled 115 participants with non-small cell lung cancer and brain neoplasms.
First-Line Chemotherapy Agents is not FDA approved. It is an investigational small molecule currently in Phase 2 clinical development for non-small cell lung cancer. The drug remains under study and has not completed the regulatory approval process.