NSCLC metastatic/molecular target

Ongoing protocols: click on the protocol for the inclusion and exclusion criteria (update 12/09/2021)

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 fusion
Currently no open trials

AKTmut
TAPISTRY (Roche) (1st and 2nd line)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

KRAS G12C
CODEBREAK100 (Amgen) (2nd and further line)
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.

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)

C-MET
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 exon 20
ZENITH20 (Spectrum) (1st and 2nd line) 
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)

TAPISTRY (Roche) (1st and 2nd line)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
(currently on hold)

PYRAMID-1 (Jiangsu) (2nd line)
A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation Who Progressed on or After Treatment With Platinum Based Chemotherapy.

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.

TAPISTRY (Roche) (1st and 2nd line)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

PIK3CA
TAPISTRY (Roche) (1st and 2nd line)
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

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