NSCLC metastatic/molecular target

Ongoing protocols: click on the protocol for the inclusion and exclusion criteria (update 10/05/2021)

EGFR common mutations
MARIPOSA (Janssen Research & Development) (1st line) - exon 19 or exon 21
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

INSIGHT-2 (Merck) (2nd line) - EGFR + cMET amplification
A Study of Tepotinib Plus Osimertinib in Epidermal Growth Factor Receptor (EGFR ) Tyrosine Kinase Inhibitor (TKI) Relapsed Mesenchymal-epithelial Transition Factor (MET) Amplified Non-small Cell Lung Cancer (NSCLC).

FLOSI (Academic) (1st line) 
Local AblativeTherapy for Oligoprogressive Non-Small-Cell Lung Cancer Treated With First-line OSImertinib. 

EGFR uncommon mutations
ZENITH20 (Spectrum) (1st and 2nd line) - all
A Phase 2 Study of Poziotinib in Patients with Non-small cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation.
(cohort 3 closed, cohort 4-5-6-7 open)

Papillon (Janssen) (1st line) - exon20 insertion
A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

ALK
Currently no open trials

KRAS G12C
CodeBreak 200 (Amgen) (2nd and 3rd line after chemo- and immunotherapy) 
A phase 3 study to compare AMG510 with docetaxel in NSCLC subjects with KRAS p.G12C mutation
(currently on hold)


RET
LIBRETTO-431 (Eli Lilly) (1st line) - RET fusion
A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing LOXO-292 to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer.

BRAF
LXH254, LTT462 (Novartis) (end-line) - BRAF non-V600 and BRAFV600
A Phase Ib, open-label, multicenter study of oral LXH254 in combination with oral LTT462 in adult patients with advanced or metastatic KRAS or BRAF mutant Non-Small Cell Lung Cancer.
(only cohort for BRAF open)

BFAST (Roche) (1st line) - BRAFV600
A phase II/III multicentre study evaluating the efficacy and safety of multiple targeted therapies as treatments for patients with advanced or metastatic non-small cell lung cancer (NSCLC) harbouring actionable somatic mutations detected in blood (B-Fast: blood-first assay screening trial).
(only cohort E open)

C-MET
CINC280J12201 (Novartis) (1ste line) - METex14mutation
Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations.

Geometry III (Novartis) (2nd and 3rd line after chemo- and immunotherapy)  - METex14mutation
Study of Capmatinib Efficacy in Comparison With Docetaxel in Previously Treated Participants With Non-small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutation.

ROS1
TRIDENT-1 (TurningPoint) (1st, 2nd and 3rd line)
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements.

HER2
ZENITH20 (Spectrum) (1st and 2nd line)  - exon20 insertion
A Phase 2 Study of Poziotinib in Patients with Non-small cell Lung Cancer (NSCLC), Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation.
(cohort 3 closed, cohort 4-5-6-7 open)

NTRK
TRIDENT-1 (TurningPoint)  (1st, 2nd and 3rd line)
A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements.

3th line (all mutations)
ImmunoSABR (Academic)
Combination of SABR and L19-IL2 in Patients With Stage IV Lung Cancer.