GEN1046 for Non-Small Cell Lung Cancer Metastatic

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Cancer MetastaticGEN1046 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, GEN1046, to see if it is safe and effective in treating patients with non-small cell lung cancer who have progressed after previous treatment.

Eligible Conditions
  • Non-Small Cell Lung Cancer Metastatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Progression-free survival will be assessed from first treatment until 6 months after last subjects first treatment

Month 6
Incidence and severity of adverse events and laboratory abnormalities
Month 6
Duration of response
Year 3
Overall survival (OS)
Month 6
Time to response (TTR)
Month 6
Progression-free survival (PFS)
Month 6
Duration of response (DOR)
Month 6
Overall survival
Month 6
Progression-free survival
Month 6
Objective response rate (ORR)
Day 90
Incidence and severity of adverse events (AEs) and laboratory abnormalities
Month 6
Time to response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Asthenia
17%Dyspnoea
16%Vomiting
14%Pyrexia
14%Dizziness
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Insomnia
11%Pruritus
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Abdominal pain
7%Blood creatinine increased
7%Hypokalaemia
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Hyperthyroidism
5%Dyspepsia
5%Dysphagia
5%Chest pain
5%Blood alkaline phosphatase increased
5%Musculoskeletal pain
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Urinary tract infection
4%Hypotension
2%Death
2%Acute kidney injury
2%Pneumonitis
2%Pulmonary embolism
2%Atrial fibrillation
1%Neutropenic sepsis
1%Inappropriate antidiuretic hormone secretion
1%Diabetes mellitus
1%Hemiparesis
1%Transient ischaemic attack
1%Superior vena cava syndrome
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Trial Design

3 Treatment Groups

Arm B
1 of 3
Arm A
1 of 3
Arm C
1 of 3

Experimental Treatment

160 Total Participants · 3 Treatment Groups

Primary Treatment: GEN1046 · No Placebo Group · Phase 2

Arm BExperimental Group · 2 Interventions: Pembrolizumab, GEN1046 · Intervention Types: Biological, Biological
Arm A
Biological
Experimental Group · 1 Intervention: GEN1046 · Intervention Types: Biological
Arm CExperimental Group · 2 Interventions: Pembrolizumab, GEN1046 · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: progression-free survival will be assessed from first treatment until 6 months after last subjects first treatment

Who is running the clinical trial?

BioNTech SEIndustry Sponsor
51 Previous Clinical Trials
90,788 Total Patients Enrolled
GenmabLead Sponsor
44 Previous Clinical Trials
8,708 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years of age.
You have stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease.
You have adequate organ and bone marrow function as defined in the protocol.