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NZV930 for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of new cancer drugs NZV930, PDR001, and NIR178, either alone or in combination.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Prostate Cancer
- Breast Cancer
- Pancreatic Cancer
- Colorectal Cancer
- Ovarian Cancer
- Kidney Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability of the NZV930 in combination with PDR001 and/or NIR178
Secondary outcome measures
Clinical Benefit Rate (CBR)
Overall response rate (ORR)
Plasma concentration vs. time profiles for NIR178 and derived PK parameters
+3 moreSide effects data
From 2019 Phase 1 & 2 trial • 172 Patients • NCT0232573958%
Diarrhoea
50%
Aspartate aminotransferase increased
42%
Hyperphosphataemia
33%
Pyrexia
33%
Anaemia
33%
Alanine aminotransferase increased
25%
Blood bilirubin increased
25%
Abdominal distension
25%
Fatigue
17%
Neutrophil count decreased
17%
Oedema peripheral
17%
Abdominal pain
17%
Nausea
17%
Nasopharyngitis
17%
Gamma-glutamyltransferase increased
17%
Arthralgia
17%
Back pain
17%
Rash
17%
Pruritus
17%
Hot flush
8%
Oesophageal varices haemorrhage
8%
Flank pain
8%
Dysgeusia
8%
Myalgia
8%
Tinea cruris
8%
Hyperglycaemia
8%
Liver carcinoma ruptured
8%
Oedema
8%
Blood creatinine increased
8%
Hypokalaemia
8%
Palpitations
8%
Abdominal discomfort
8%
Headache
8%
Constipation
8%
Vomiting
8%
Folliculitis
8%
Rash pustular
8%
Sinusitis
8%
Bilirubin conjugated increased
8%
Blood albumin decreased
8%
Blood creatine phosphokinase increased
8%
Blood phosphorus decreased
8%
Weight decreased
8%
Platelet count decreased
8%
Hyponatraemia
8%
Insomnia
8%
Dyspnoea exertional
8%
Peripheral sensory neuropathy
8%
Cough
8%
Dysphonia
8%
Epistaxis
8%
Pneumonitis
8%
Productive cough
8%
Dry skin
8%
Hyperthyroidism
8%
Blood alkaline phosphatase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Patients of Combination Dose
Phase I: FGF401 120 mg + PDR001 300 mg
Phase I: 120 mg Fed
Phase I: 150 mg Fasted
Phase II: Group 1 - FGF401 120 mg QD
Phase II: Group 2 - FGF401 120 mg QD
Phase II: Group 3 - FGF401 120 mg QD
All Patients of Single Agent FGF401
Phase I: FGF401 80 mg + PDR001 300 mg
All Patients
Phase I: 50 mg Fasted
Phase I: 80 mg Fasted
Phase I: 80 mg Fed
Phase I: 120 mg Fasted
Trial Design
4Treatment groups
Experimental Treatment
Group I: NZV930 with PDR001 Doublet TherapyExperimental Treatment2 Interventions
Combination of NZV930 with PDR001
Group II: NZV930 with NIR178 Doublet TherapyExperimental Treatment2 Interventions
Combination of NZV930 with NIR178
Group III: NZV930 with NIR178 & PDR001 Triplet TherapyExperimental Treatment3 Interventions
Combination of NZV930 with NIR178 and PDR001
Group IV: NZV930 MonotherapyExperimental Treatment1 Intervention
Single Agent NZV930
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,117 Total Patients Enrolled
Frequently Asked Questions
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