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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) + Yervoy (ipilimumab) (CTLA4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pan-Asian adapted Clinical Practice Guidelines for the management of patients with metastatic non-small-cell lung cancer: a CSCO–ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS
Published date:
12/28/2018
Excerpt:
Recommendation 5: first-line treatment of NSCLC without a druggable oncogene driver: Nivolumab plus ipilimumab represents a treatment option regimen for patients with PS 0–1, EGFR and ALK negative NSCLC with a high TMB, regardless of tumour PD-L1 expression level, if approved and available [A¼83%, B¼17% and I, A].
DOI:
10.1093/annonc/mdy554
Source:
Title:
Concurrent or Sequential Immunotherapy and Radiation Therapy in Patients With Metastatic Lung Cancer
Excerpt:
...Patients whose tumors known to harbor an exon 19 deletion or exon 21 L858R EGFR mutation must have progressed on or had intolerance to an EGFR TKI....
Source:
Title:
Study of Nivolumab Verses Nivolumab and Ipilimumab Combination in EGFR Mutant Non-small Cell Lung Cancer
Excerpt:
...3rd generation EGFR TKI for patients with T790M mutation is allowed...
Trial ID:
More C2 evidence
Source:
Title:
Nivolumab in Combination With Chemotherapy, or Nivolumab in Combination With Ipilimumab, in Advanced EGFR-Mutant or ALK-Rearranged NSCLC
Excerpt:
...- EGFR-mutant...
Trial ID:
Source:
Title:
Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer
Excerpt:
...- Newly diagnosed, treatment-naïve (except for prior surgery) metastatic NSCLC, with or without a targetable oncogenic driver alteration: sensitising EGFR-mutation (exon 19-del and 21-L858R), ALK- or ROS1-fusion....
Trial ID:
Source:
Title:
Intrathecal Double Checkpoint Inhibition
Excerpt:
...- Requirements for patients with non-small cell lung cancer: non-small cell lung cancer without a specified targetable oncogenic driver alteration: sensitising Epidermal Growth Factor Receptor (EGFR) mutation (exon 19-del and 21-L858R), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene-1 (ROS1) rearrangement....
Trial ID:
Source:
Title:
A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
Excerpt:
...- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with any actionable mutation or translocation in EGFR, ALK, or ROS1...
Trial ID:
Source:
Title:
Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer
Excerpt:
...- Patients with known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement are eligible...
Trial ID:
Source:
Title:
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer
Excerpt:
...Patients with NSCLC tumor known to harbor a genomic aberration for which FDA approved treatment is available (i.e, non-resistant EGFR mutations, EGFR T790M mutation, ALK rearrangement, ROS rearrangement, BRAF V600E mutation) are allowed to enroll if they have received prior treatment with the FDA approved targeted therapy....
Trial ID:
Source:
Title:
A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
Excerpt:
...- Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but...
Trial ID:
Source:
Title:
Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer
Excerpt:
......
Trial ID:
Source:
Title:
Ipilimumab and Nivolumab in Patients With Anti-PD-1-axis Therapy-resistant Advanced Non-small Cell Lung Cancer.
Excerpt:
...Patients with NSCLC known to harbor an ALK rearrangement, or EGFR mutation known to be sensitive to FDA-approved tyrosine kinase inhibitors (TKI), are only eligible after experiencing disease progression (during or after treatment) or intolerance to an FDA approved EGFR TKI or ALK TKI, respectively....
Less C2 evidence
Source:
Title:
A Randomized Phase 2 Trial of Nivolumab Versus Nivolumab-Ipilimumab Combination in EGFR-Mutant NSCLC
Published date:
09/21/2022
Excerpt:
…we designed a trial to test the activity of combination nivolumab (N)-ipilimumab (NI) in EGFR-mutant NSCLC….Five patients derived clinical benefits from ICI with one objective response (objective response rate 3.2%), and median progression-free survival was 1.22 months (95% confidence interval: 1.15-1.35) for the overall cohort.
DOI:
10.1016/j.jtocrr.2022.100416
Trial ID:
Source:
Title:
First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in advanced non-small cell lung cancer: a subanalysis of Asian patients in CheckMate 9LA
Published date:
02/19/2022
Excerpt:
At a minimum follow-up of 12.7 months, median OS was not reached with nivolumab plus ipilimumab combined with chemotherapy versus 13.3 months with chemotherapy [hazard ratio (HR) 0.33; 95% confidence interval (CI) 0.14-0.80]. Median PFS was 8.4 versus 5.4 months (HR 0.47; 95% CI 0.24-0.92) and ORR was 57% versus 23%, respectively. Grade 3-4 treatment-related adverse events were observed in 57% versus 60% of patients, respectively.Consistent with results in the all randomized population, nivolumab plus ipilimumab combined with chemotherapy improved efficacy in the Asian subpopulation versus chemotherapy alone and had a manageable safety profile, supporting its use as first-line treatment for advanced NSCLC in Asian patients.
Secondary therapy:
Chemotherapy
DOI:
10.1007/s10147-022-02120-0
Source:
Title:
Nivolumab plus ipilimumab as first-line treatment for advanced non-small-cell lung cancer (CheckMate 012): results of an open-label, phase 1, multicohort study
Published date:
12/05/2016
Excerpt:
Eligible patients were aged 18 years or older with histologically or cytologically confirmed recurrent stage IIIb or stage IV, chemotherapy-naive NSCLC….Between May 15, 2014, and March 25, 2015, 78 patients were randomly assigned to receive nivolumab every 2 weeks plus ipilimumab every 12 weeks (n=38) or nivolumab every 2 weeks plus ipilimumab every 6 weeks (n=40)....In patients with EGFR-mutant NSCLC, four (50%) of eight had an objective response; appendix p 5).
DOI:
10.1016/S1470-2045(16)30624-6
Trial ID:
