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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Xegafri (rociletinib) (EGFR inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Efficacy and Safety of Rociletinib Versus Chemotherapy in Patients With EGFR-Mutated NSCLC: The Results of TIGER-3, a Phase 3 Randomized Study
Published date:
10/26/2020
Excerpt:
Patients with advanced or metastatic EGFR-mutated NSCLC with disease progression on standard therapy (previous EGFR TKI and platinum-based chemotherapy) were randomized to oral rociletinib (500 or 625 mg twice daily) or single-agent chemotherapy (pemetrexed, gemcitabine, docetaxel, or paclitaxel)....Rociletinib had a more favorable median PFS versus chemotherapy but had higher rates...
DOI:
10.1016/j.jtocrr.2020.100114
Trial ID:
Source:
Title:
TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
Excerpt:
...Documented evidence of a tumor with 1 or more EGFR activating mutations excluding exon 20 insertion 3....
Source:
Title:
Rociletinib (CO-1686) USA Expanded Access Program
Excerpt:
...- Unresectable locally advanced or metastatic NSCLC with EGFR activating mutation (excluding exon 20 insertion) and presence of the T790M mutation...
More C2 evidence
Source:
Title:
A Phase 1b/2 Study of Safety and Efficacy of Rociletinib in Combination With MPDL3280A in Patients With Advanced or Metastatic EGFR-mutant NSCLC
Excerpt:
...- Histologically or cytologically documented metastatic or unresectable, locally advanced or metastatic NSCLC, with one or more activating EGFR mutation (eg, G719X, exon 19 deletion, L858R, L861Q) and absence of exon 20 insertion...
Trial ID:
Source:
Title:
TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy
Excerpt:
...Documented evidence of a tumor with activating EGFR mutations by local testing....
Trial ID:
Source:
Title:
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
Excerpt:
...- Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC with EGFR activating mutation (excluding exon 20 insertion); measurable disease per RECIST 1.1...
Trial ID:
Source:
Title:
Study to Evaluate Safety, Pharmacokinetics, and Efficacy of Rociletinib (CO-1686) in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) in Non-Small Cell Lung Cancer (NSCLC) Patients
Excerpt:
...Evidence of a tumor with one or more EGFR mutations excluding exon 20 insertion 3....
Source:
Title:
A Phase 2/3 clinical study to evaluate the safety and efficacy of the study medication CO-1686 compared to erlotinib in subjects with Non-Small Cell Lung Cancer
Excerpt:
...Documented evidence of a tumor with one or more activating EGFR mutations excluding exon 20 insertion3. ...
Trial ID:
