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Association details:
| Biomarker: | EGFR mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) |
| Direction: | Resistant |
Evidence:
Excerpt:
OPDIVO, as monotherapy is indicated for the treatment of locally advanced or metastatic non squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, OPDIVO should be used after progression on or after targeted therapy.
Source:
Title:
A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy
Excerpt:
...Overall survival (OS)`Progression-free survival (PFS)`Time to next therapy (TTNT)`Best overall response rate (BORR)`Distribution of participant demographics characteristics: Age`Distribution of participant demographics characteristics: Sex`Distribution of clinical characteristics: Smoking status`Distribution of clinical characteristics: ECOG at initial diagnosis and at nivolumab initiation`Distribution of clinical characteristics: Histology`Distribution of clinical characteristics: TNM classification`Distribution of clinical characteristics: Location of metastases`Distribution of clinical characteristics: EGFR mutation`Distribution of clinical characteristics: ALK translocation`Distribution of clinical characteristics: HER2 mutation`Distribution of clinical characteristics: BRAF mutation`Distribution of clinical characteristics: KRAS mutation`Distribution of clinical characteristics: ROS1 mutation`Distribution of clinical characteristics: MET mutation`Distribution of clinical characteristics: PD-L1 expression`Distribution of clinical characteristics: PD-L1 expression on tumor or stromal cells`Incidence of Adverse Drug Reactions`Incidence of Seriousness criteria`Incidence of Intensity/ Grade`Incidence of AE duration`Incidence of Action taken regarding the BMS treatment`Incidence of Incidence rate...
Trial ID:
Source:
Title:
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
Excerpt:
...The patient's tumor must be free of EGFR gene-sensitive mutations (including but...
Trial ID:
More C2 evidence
Source:
Title:
NIVORAD - A randomised phase 2 trial of nivolumab and stereotactic ablative body radiotherapy in advanced non-small cell lung cancer, progressing after first or second line chemotherapy.
Excerpt:
...These may include biomarkers which are often studied amongst patients with non-small cell lung cancer such as PD-L1 expression, EGFR and KRAS mutational status but also novel biomarkers relating to effects of radiation on the immune response. ...
Trial ID:
Source:
Title:
Dose Escalation of DF6002 in Patients With Advanced Solid Tumors, and Expansion in Selected Indications
Excerpt:
...Status for actionable mutations (e.g., EGFR, ALK, ROS1, RET, etc.) must be known (when testing is available as per country/region standard of care practices); participants with actionable mutations must have received and progressed on, have been intolerant to, or...
Source:
Title:
Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC
Excerpt:
...Patient deemed able to complete neoadjuvant therapy according to their EGFR/ALK mutation status and specific histology (if clinically appropriate) and per the manufacturer's systemic therapy labeling 5....
Trial ID:
Source:
Title:
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer
Excerpt:
...- Patients with activating Epidermal Growth Factor Receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor....
Trial ID:
Source:
Title:
A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Excerpt:
...- Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but...
Trial ID:
Source:
Title:
A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer
Excerpt:
...More than one molecular inhibitor is allowed such as a first generation EGFR inhibitor followed by a next generation EGFR inhibitor when T790 mutation develops....
Trial ID:
Source:
Title:
F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer
Excerpt:
...Patients with a known sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with afatinib, erlotinib, gefitinib, or another EGFR-TKI approved for the treatment of EGFR-mutant NSCLC....
Trial ID:
Source:
Title:
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC
Excerpt:
...or, Subjects with a documented activating mutation {e.g., against epidermal growth factor receptor (EGFR), against rearranged anaplastic lymphoma kinase (ALK), Proto-oncogene tyrosine-protein kinase (ROS)} must have received the appropriate targeted therapy....
Trial ID:
Source:
Title:
Nivolumab and Metformin Hydrochloride in Treating Patients With Stage III-IV Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
Excerpt:
...in such cases, documentation of EGFR mutation or ALK translocation status should be provided if available...
Trial ID:
Source:
Title:
Nivolumab in Treating Patients With Advanced Metastatic Non-small Cell Lung Cancer
Excerpt:
...- Patients with activating epidermal growth factor receptor (EGFR) mutations must have received an EGFR tyrosine kinase inhibitor directed therapy prior to platinum therapy...
Trial ID:
Less C2 evidence
Source:
Title:
A Randomized Phase 2 Study Comparing Nivolumab with Carboplatin-Pemetrexed for EGFR-Mutated NSCLC with Resistance to EGFR Tyrosine Kinase Inhibitors (WJOG8515L)
Published date:
12/17/2021
Excerpt:
Patients with EGFR-mutated NSCLC who acquired EGFR-TKI resistance not due to a secondary T790M mutation of EGFR were randomized 1:1....Median PFS and 1-year PFS probability were 1.7 months and 9.6% for nivolumab versus 5.6 months and 14.0% for carboplatin-pemetrexed [log-rank P < 001; hazard ratio (HR) of 1.92, with a 60% confidence interval (CI) of 1.61-2.29]. Overall survival was 20.7 and 19.9 months [HR = 0.88 (95% CI, 0.53-1.47)], and response rate was 9.6% and 36.0% for nivolumab and carboplatin-pemetrexed, respectively. No subgroup including patients with a high tumor mutation burden showed a substantially longer PFS with nivolumab than with carboplatin-pemetrexed....Nivolumab did not confer a longer PFS compared with carboplatin-pemetrexed in the study patients.
DOI:
10.1158/1078-0432.CCR-21-3194
