Trials

Study NumberTitleIndicationMarkerStatus
Bioluma

A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition.

Cohort 1: Subjects with histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer who present with stage IIIB/IV disease after failure of platinum-based first-line therapy (second line) – recruitment of cohort 1 is stopped

Cohort 2: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer and high tumor mutation burden after failure of platinum-based first-line therapy (second line).

no markerActive Trial
CINC280I12201

A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%

Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC as first-line setting.

PD-L1Active Trial
Theros

Exploring the theragnostic value of osimertinib in EGFR-mutated lung cancer (THEROS) - A multicentric phase II study in patients with TKI-resistant EGFR-mutated lung cancer exhibiting early metabolic response to osimertinib

EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance to erlotinib, gefitinib or afatinib who are “unknown” for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay.

EGFRActive Trial
TRIDENT

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 ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC as first-line setting.

NTRK, ROS1Active Trial
EATON

An open-label, multicenter, phase I dose-escalation trial of EGF816 and trametinib in patients with non-small cell lung cancer, activating EGFR mutation and resistance to 1st, 2nd or 3rd generation EGFR TKI therapy

Patients with advanced non-small cell lung cancer harbouring sensitizing EGFR mutations (EGFR del19 or EGFR p.L858R) with progression upon treatment with 1st or 2nd generation EGFR TKI and acquired resistance mutation EGFR p.T790M

EGFRActive Trial
CEGF816X2102

A phase Ib, open label, multi-center study to characterize the safety, tolerability and preliminary efficacy of EGF816 in combination with selected targeted agents in EGFRmutant NSCLC

This is a Phase Ib, open label, non-randomized dose escalation study of EGF816 in combination with ribociclib, trametinib, or LXH254, followed by dose expansion of EGF816 in combination with ribociclib, trametinib, LXH254, INC280, or gefitinib in adult patients with advanced EGFR-mutant NSCLC. Patients must be either treatment-naïve in the advanced setting and harbor a sensitizing mutation in EGFR (ex19del or L858R) or have progressed on a 1st or 2nd generation EGFR TKI (e.g., erlotinib, gefitinib, afatinib) and harbor an EGFR T790M mutation within the tumor. Patients should not have previously received a 3rd generation EGFR TKI (e.g., osimertinib, rociletinib, ASP8273).

EGFRActive Trial
FIND

A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced squamous NSCLC (sqNSCLC) harboring FGFR genetic alterations after relapse of standard therapy.

Cohort 1: Activating (high confidence) FGFR translocations (max. 15 patients)
Cohort 2: Activating (high confidence) hotspot FGFR mutations (max. 15 patients)
Cohort 3: Activating (low confidence) FGFR alteration (max. 20 patients)

FGFRActive Trial
STARTRK-2

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3 or ROS1 Gene Rearrangements.

Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3 or ROS1 gene rearrangement that is predicted to translate into a fusion protein with a functional TrkA/B/C or ROS1 kinase domain, respectively, without a concomitant second oncodriver (e.g., EGFR, KRAS). These are patients for whom no alternative effective standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.

NTRKTrial in preparation