Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Second line chemotherapy · 2 trials · 2 indications
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.
Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
| 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. |
| Trastuzumab + 2nd Line Chemotherapy | EXPERIMENTAL | - |
| Only Chemotherapy | ACTIVE_COMPARATOR | - |
| 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. |
| Second line chemotherapy | DRUG | As prescribed |
| trastuzumab [Herceptin] | DRUG | 6mg/kg iv every 3 weeks |
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 a chemotherapy regimen given after an initial, or first line, treatment has stopped working or is no longer tolerated. It is used in cancers including breast cancer and non-squamous non-small cell lung cancer, and is studied in trials such as NCT00444587 and NCT01328951.
Second line chemotherapy is used in HER2 positive metastatic breast cancer after first line treatment. A Phase 2 trial, NCT00444587, evaluated Herceptin (trastuzumab) in combination with second line chemotherapy in patients with HER2 positive metastatic breast cancer.
Second line chemotherapy is used in non-squamous non-small cell lung cancer. The Phase 3 trial NCT01328951 studied first line maintenance erlotinib versus erlotinib at disease progression in participants with advanced NSCLC who had not progressed following platinum based chemotherapy.
Roche Holding AG, which trades under the ticker RHHBY, is the developer associated with second line chemotherapy. The company sponsored the clinical trials evaluating this treatment approach in breast cancer and non-squamous non-small cell lung cancer.
Second line chemotherapy has been studied in Phase 2 and Phase 3 clinical trials. It is an investigational treatment approach and is not described as approved. The Phase 2 trial NCT00444587 and the Phase 3 trial NCT01328951 have both been completed.
Second line chemotherapy has been evaluated in two completed trials. NCT00444587 was a Phase 2 study of Herceptin plus second line chemotherapy in HER2 positive metastatic breast cancer, and NCT01328951 was a Phase 3 study of erlotinib timing in advanced non-squamous non-small cell lung cancer.