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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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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 more

Side effects data

From 2019 Phase 1 & 2 trial • 172 Patients • NCT02325739
58%
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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~19 spots leftby Apr 2025