A clinical study to assess the safety, tolerability, and anti-tumour activity of the investigational drug (bemcentinib) in combination with the standard of care (a chemotherapy drug combination consisting of pembrolizumab plus pemetrexed and carboplatin) in adult patients with a type of advanced or metastatic lung cancer called non-squamous non-small cell lung cancer.
- Conditions
- untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutationMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003806-28-PL
- Lead Sponsor
- BerGenBio ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 64
1. The subject (or legally acceptable representative, if applicable) must provide written
informed consent for the study prior to any screening procedures.
2. Be = 18 years of age on the day of signing the informed consent.
3. Have a histologically- or cytologically confirmed diagnosis of advanced (Stage IIIb/IIIc)
or metastatic (Stage IV) (AJCC Edition 8) non-squamous NSCLC not amenable to
curative therapy, irrespective of PD-L1 status and without actionable mutations
(Phase 1b).
4. Have a histologically- or cytologically confirmed diagnosis of advanced (Stage
IIIb/IIIC) or metastatic (Stage IV) (AJCC, Edition 8) non-squamous NSCLC with STK11
m, not amenable to curative therapy, irrespective of PD-L1 status and without
actionable mutations (Phase 2a).
5. Participants who received prior neo-adjuvant or adjuvant/consolidation treatment
(radiotherapy, chemotherapy, immunotherapy) or chemoradiotherapy with curative
intent for non-metastatic disease must have experienced a treatment-free interval of
at least 6 months since the last dose of chemotherapy, immunotherapy and/or
radiotherapy before enrollment
6. Have measurable disease per RECIST 1.1 as assessed by the investigator. Lesions
situated in a previously irradiated area are considered measurable if progression has
been demonstrated in such lesions.
The exhaustive list of the inclusion criteria is available in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
1. Has received any prior chemotherapy or biological therapy for advanced
(Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC.
2. Has any actionable mutation that is considered targetable with first-line treatment.
3. Has a known history of prior malignancy except if the subject has undergone
potentially curative therapy with no evidence of disease recurrence for 3 years since
initiation of that therapy.
4. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Subjects with previously treated brain metastases may participate,
provided they are radiologically stable, i.e. without evidence of progression for at least
2 weeks and have no evidence of new or enlarging brain metastases and are off steroids
7 days prior to dosing with study medication. Stable brain metastases by this definition
should be established prior to the first dose of study medication. Subjects with
asymptomatic brain metastases (i.e. no neurological symptoms, no requirements for
corticosteroids, and no lesion >1.5cm) may participate but will require regular imaging
of the brain as a site of disease. Subjects who have
experienced an acute neurological event (e.g. intracranial or
subarachnoid haemorrhage, stroke, intracranial trauma) within 6
months prior to study enrolment will be excluded.
5. History of the following cardiac conditions:
a. Congestive cardiac failure of >Grade II severity according to the New
York Heart Association (NYHA) or
resistant or inadequately treated heart failure.
b. Ischemic cardiac event including myocardial infarction prior to first dose or hospitalization for
unstable angina within 3 months prior to first dose.
c. Abnormal left ventricular ejection fraction on echocardiography or multigated
acquisition scan (MUGA) (less than the lower limit of normal for a subject of
that age at the treating institution or <45%, whichever is lower), or history of cardiomyopathy or left ventricular hypertrophy.
d. Uncontrolled cardiac disease, including unstable angina, uncontrolled
hypertension (i.e. sustained systolic blood pressure (BP) >160 mmHg or
diastolic BP >90 mmHg), or need to change medication due to lack of disease
control within 12 weeks prior to the provision of consent.
e. History or presence of sustained bradycardia (=55 bpm) or history of
symptomatic bradycardia, left bundle branch block, cardiac pacemaker or
significant arrhythmias or any conduction disorder within 6 months prior
to dosing as defined by the need for treatment.
f. Family history of long QTc syndrome or ventricular arrhythmias; personal
history of long QTc syndrome or previous drug induced QTc prolongation of at
least Grade 3 (QTc >500ms).
g. Presence of any other risk factors that increase the risk of QTc prolongation,
specifically, hypokalemia or hypomagnesemia (if corrected the subject may be
enrolled) or inadequately treated hypothyroidism (defined as thyroid
stimulating hormone (TSH) below the expected range).
h. Current treatment with any agent known to cause QT prolongation and have a
risk for Torsades de pointes (TdP), which cannot be discontinued at least 5 and
½ half-lives or 2 weeks prior to the first dose of study treatment, with the
exception of antiemetics (e.g. ondansetron) which may be required. Please see
https://crediblemeds.org for a list of medications with known TdP
risk that need to be excluded.
The exhaustive list of the exclusion criteria is available in
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method