JCA — NSCLC

Dossier modules

• JCA_SCOPE

  Scoping (130d, member states submit PICOs)

  required44%
• JCA_DOSSIER

  HTD dossier (100d company submission, 60d in accelerated)

  required78%
• JCA_CLIN

  JCA clinical assessment report (assessors ~200d)

  required57%

PICO questions (7)

EU JCA scoping consolidates PICOs from member states — expect 5-20+. Each member state may pick a different comparator / subpopulation.

1. JCA-PICO-01jca_scope:FR
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: pembrolizumab monotherapy; platinum doublet chemotherapy; atezolizumab

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
2. JCA-PICO-02jca_scope:PL
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: platinum doublet chemotherapy; atezolizumab

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
3. JCA-PICO-03jca_scope:DK
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: platinum doublet chemotherapy; atezolizumab; pembrolizumab monotherapy

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
4. JCA-PICO-04jca_scope:PT
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: atezolizumab; pembrolizumab monotherapy

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
5. JCA-PICO-05jca_scope:PL
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: atezolizumab; platinum doublet chemotherapy; pembrolizumab monotherapy

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
6. JCA-PICO-06jca_scope:PT
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: pembrolizumab monotherapy; platinum doublet chemotherapy

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)
7. JCA-PICO-07jca_scope:IT
   P: Adults with metastatic NSCLC, PD-L1 TPS≥50%, no prior systemic therapy

   I: Test drug, monotherapy, q3w until progression

   C: platinum doublet chemotherapy; pembrolizumab monotherapy; atezolizumab

   O: overall survival, PFS, ORR, DoR, AEs ≥G3, HRQoL (EORTC QLQ-C30)