Approval Probability
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Second-Line Chemotherapy · 1 trial · 1 indication
Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.
Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.
Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.
| Arm | Type | Description |
|---|---|---|
| Early Erlotinib | EXPERIMENTAL | Participants will receive blinded erlotinib as 150 mg PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment. |
| Late Erlotinib | PLACEBO_COMPARATOR | Participants will receive blinded placebo tablets PO once daily in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrate disease progression may be unblinded to receive second-line erlotinib as 150 mg PO once daily until disease progression, death, or unacceptable toxicity. Participants may be observed during a final SFU period after discontinuation from study treatment. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity. |
| Erlotinib | DRUG | Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo. |
| Second-Line Chemotherapy | DRUG | Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator. |
Inclusion Criteria: * Adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18 * Advanced or recurrent (Stage IIIB) or metastatic (Stage IV) NSCLC * Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less ...
Second line chemotherapy is used for treating Breast Cancer and Non-Squamous Non-Small Cell Lung Cancer. It is an oncology treatment developed by Roche Holding AG. The drug is currently in Phase 2 clinical development for these indications.
Second line chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's effectiveness in treating certain types of cancer.
Second line chemotherapy is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for its potential use in treating Breast Cancer and Non-Squamous Non-Small Cell Lung Cancer.
Second line chemotherapy has been studied in clinical trials including NCT00444587, a Phase 2 study of Herceptin in combination with 2nd-line chemotherapy in HER2 positive metastatic breast cancer patients, and NCT01328951, a Phase 3 study of erlotinib in advanced non-small cell lung cancer. Both trials are completed.
Second line chemotherapy is not the same as Herceptin. Herceptin is a specific drug used in combination with second-line chemotherapy in a clinical trial for HER2 positive metastatic breast cancer. Second line chemotherapy refers to the treatment regimen given after initial therapy has not worked.