Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Tata Memorial Centre Research Administration Council (TRAC)
Eligibility
Inclusion criteria
Inclusion criteria: 1)Age more than 18 years 2)ECOG PS 0-2 3)Histologically confirmed non-small cell lung cancer (adenocarcinoma, adeno-squamous, squamous or NSCLC-NOS) 4)Presence of uncommon EGFR mutation, defined as follows Exon 18 - G719X (G719A or S or C), E709X, or others Exon 20 - S768I, insertions (ex20ins), H773L or V774M, or other non-T790M uncommon variants Exon 21 - L861Q and other non-L858R uncommon variants Compound - uncommon-common or uncommon-uncommon combinations, as detected by validated testing methods (PCR-based assay, NGS, or other). 5)Stage III, IV disease (unresectable or metastatic) OR earlier-stage disease that unresectable due to comorbidities or subsequently developed recurrence or metastasis and received systemic therapy at HBCHRC. 6)Received at least one line of systemic anticancer therapy at HBCHRC (EGFR-TKI, chemotherapy, immunotherapy, or combination) 7)Availability of baseline clinical and mutation data
Exclusion criteria
Exclusion criteria: 1)Patients with only common sensitizing EGFR mutations (exon 19 deletion, L858R) without any uncommon component. 2)Patients with EGFR T790M alone at baseline without another uncommon EGFR mutation. Small cell lung cancer, squamous cell carcinoma without EGFR mutation, or other primary lung histologies. 3)Incomplete records with missing essential data on mutation type, treatment, or outcomes (for retrospective data) 4)Patients who received all their systemic treatment outside HBCHRC (insufficient follow-up or documentation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, overall survival at 1 YearTimepoint: Progression-free survival, overall survival at 1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To describe the clinical profile of NSCLC patients with uncommon EGFR mutations - Age, sex, smoking status, comorbidities, histology, stage at diagnosis, ECOG performance status, Type & distribution of uncommon EGFR mutations. 2)To evaluate treatment patterns - First-line systemic therapy (type of EGFR-TKI, chemotherapy, immunotherapy or combinations), Subsequent lines of therapy. - Use of local therapies (radiotherapy, surgery). 3)To estimate objective response rate (ORR) & disease control rate (DCR) to first-line systemic therapy. 4)To explore associations between Clinico-pathological variables (e.g., mutation subtype, stage, performance status, treatment type) & outcomes (ORR, PFS, OS at 1 Year) Timepoint: 1)1-Yr OS- Death from any cause within 12 months of registration. 2)PFS- Time from therapy start to disease progression or death at 3,6,9 & 12 months. 3)ORR & DCR- Percentage of patients with tumor shrinkage or stability at 3, 6, 9 & 12 months via RECIST. 4)Safety- Incidence of adverse events per CTCAE v6.0, assessed after each chemotherapy cycle. | — |
Countries
India
Contacts
Public ContactRajavel
Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur
Outcome results
None listed