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). Subjects who received adjuvant/neoadjuvant therapy or definitive chemoradiation and develop recurrence or progression, with evidence of stage IIIB-IV disease within 6 months after completion of therapy, are eligible.
Cohort 2: Subjects with histologically or cytologically confirmed limited-stage or extensive-stage small cell lung cancer after failure of platinum-based first-line therapy (second line).

no markerActive Trial
EATON

An open-label, multicenter, phase I dose-escalation trial of EGF816 and trametinib in patients with non-small cell lung cancer and acquired EGFR p.T790M positive resistance to 1st or 2nd 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
BAY1163877 / 19774 ROCOCO

Phase 1 study of the combination of rogaratinib with copanlisib in patients with FGFR-positive, locally advanced or metastatic solid tumors.

Dose escalation part: locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

Dose expansion part: locally advanced or metastatic urothelial carcinoma that is mRNA-positive for at least one FGFR1-4 subtype.

FGFRActive Trial
CNIR178X2201

A Phase II, multi-center, open label study of NIR178 in combination with PDR001 in patients with selected advanced solid tumors and non-Hodgkin lymphoma

Histologically confirmed diagnosis of advanced/metastatic NSCLC, histologically confirmed renal cell carcinoma (RCC), pancreatic cancer, urothelial cancer, head and neck squamous cell carcinoma (HNSCC), diffuse large Bcell lymphoma (DLBCL), microsatellite stable colorectal cancer (MSS CRC), triple negative breast cancer (TNBC) or cutaneous melanoma

no markerActive Trial
CINC280D2201

A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adult patients with EGFR wild-type, ALK rearrangement negative locally advanced/metastatic non-small cell lung cancer.

• Histologically confirmed locally advanced/metastatic (stage IIIB or IV per AJCC/IASLC v. 8) NSCLC
• EGFR Wildtype
• ALK negative

no markerActive Trial
CLXH254X2102

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

Adult NSCLC patients, with confirmed diagnosis of advanced or metastatic KRAS- or BRAF V600E-mutant NSCLC who have progressed following standard of care or for whom no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment will be eligible to participate in this study.

Active Trial
CEGF816X2201C

A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer

Patients with cMet positive NSCLC

METActive Trial
CINC280A2201

A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC)

NSCLC harbouring MET mutation in second line treatment

METActive 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