Trials

Study NumberTitleIndicationMarkerStatus
CINC280X2105C

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

EGFR mutated NSCLC with and without T790m mutation from 1st line, no prior treatment with a third generation TKI.

EGFRActive Trial
CLDK378A2205

A Phase II, multi-center, open-label, five-arm study to evaluate the efficacy and safety of oral ceritinib treatment for patients with ALK-positive non-small cell lung cancer (NSCLC) metastatic to the brain and/or to leptomeninges.

NSCLC harbouring ALK rearrangement and metastatic spread to the central nervous system including the leptomeninges:
- Arm 3 will include patients with metastases in the brain without evidence of leptomeningeal carcinomatosis, previously treated with radiation to the brain but with no prior exposure to an ALKi.
- Arm 4 will include patients with metastases in the brain without evidence of leptomeningeal carcinomatosis, previously untreated with radiation to the brain and with no prior exposure to an ALKi.
- Arm 5 will include any patients with leptomeningeal carcinomatosis with or without evidence of active lesion at the baseline Gadolinium-enhanced brain MRI.

ALKActive 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)

1. NSCLC harbouring MET mutation in first line treatment or further
2. NSCLC harbouring MET amplification with GCN ≥10 in first line treatment or further

METActive Trial
BAY 16443

An open label, non-randomized, Phase I dose escalation study to characterize safety, tolerability, pharmacokinetics and maximum tolerated dose of BAY 1163877 in subjects with refractory, locally advanced or metastatic solid tumors

1. Urothelium carcinoma
2. NSCLC Adenocarcinoma and squamous cell carcinoma.

FGFRActive Trial
CEGF816X2101

A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816, administered orally in adult patients with EGFRmut solid malignancies.

Patients must have histologically or cytologically confirmed locally advanced (stage IIIB not amenable to definitive multi-modality therapy including surgery) or metastatic (stage IV) EGFR mutant NSCLC.

EGFRActive 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.

BRAF, KRASActive Trial
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
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, ROS1, or ALK Gene Rearrangements

Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement that is predicted to translate into a fusion protein with a functional TrkA/B/C, ROS1, or ALK 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.

ALK, ROS1Trial in preparation