Approval Probability
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Platinum chemotherapy · 1 trial · 1 indication
Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. PFS is the time (in months) between the date of randomization and the date of first documented disease progression or death from any cause, whichever comes first. Participants who had neither progressed nor died at the time of data cut-off or who were lost to follow-up were censored at the date of the last tumor assessment where non-progression was documented or last date of follow up for progression of disease, whichever was last. Participants without post baseline tumor assessments who were known to be alive were censored at the time of randomization. Analysis was performed using Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | po on days 15-28 of each 4 week cycle until disease progression |
| Platinum chemotherapy (cisplatin or carboplatin) | DRUG | cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles |
| erlotinib [Tarceva] | DRUG | 150mg po on days 15-28 of each 4 week cycle until disease progression |
| gemcitabine | DRUG | 1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles |
Inclusion Criteria: * adult patients, \>=18 years of age; * advanced (stage IIIB/IV)non-small cell lung cancer; * measurable disease; * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Exclusion Criteria: * prior exposure to agents directed at the HER axis; * prior chemotherap...
Platinum chemotherapy is used as first-line treatment in patients with advanced or recurrent non-squamous non-small cell lung cancer. It is administered in combination with Tarceva (erlotinib) or placebo, as studied in a Phase 3 clinical trial. The trial enrolled 451 patients across multiple countries in Asia.
Platinum chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company conducted a Phase 3 clinical trial of platinum-based therapy combined with Tarceva (erlotinib) or placebo for non-squamous non-small cell lung cancer. The trial was completed with 451 participants.
Platinum chemotherapy is in Phase 3 clinical development for non-squamous non-small cell lung cancer. The Phase 3 trial, NCT00883779, has been completed. The study was randomized, double-blind, and placebo-controlled, enrolling 451 patients with advanced or recurrent disease.
Platinum chemotherapy was studied in the completed Phase 3 clinical trial NCT00883779. This trial evaluated Tarceva (erlotinib) or placebo in combination with platinum-based therapy as first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer. The trial enrolled 451 patients in China, Hong Kong, Indonesia, Philippines, South Korea, Taiwan, and Thailand.
No, platinum chemotherapy is not the same as Tarceva (erlotinib). In the Phase 3 trial NCT00883779, platinum-based therapy was given in combination with either Tarceva or placebo. Platinum chemotherapy is a small molecule, while Tarceva is a separate drug evaluated alongside it in the study.