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Part 2, active treatment for Non-Small Cell Lung Cancer

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

Study Summary

Part 1 of the study determines the optimal dose of inupadenant to be given in combination with carboplatin and pemetrexed to patients that progressed after receiving specific first line treatments for Stage 3 or metastatic non-small cell lung cancer. Part 2 compares the efficacy of inupadenant to placebo when both are combined with carboplatin and pemetrexed for patients that progressed after receiving the same first line treatments for Stage 3 or metastatic non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Papaverine
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PBF-1129
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Study Objectives

3 Primary · 10 Secondary · Reporting Duration: From randomization to death due to any cause, assessed up to 24 months.

Day 21
Dose-finding to determine recommended Phase 2 dose
Week 3
Area under the concentration-time curve (AUCinf)
Plasma half-life (T-1/2)
Month 24
Efficacy (Patient Reported Outcomes)
Therapeutic procedure
Hour 24
Peak plasma concentration (Cmax)
Time to peak plasma concentration (Tmax)
Month 24
Duration of Response [Efficacy]
Month 24
Overall Survival [Efficacy]
Month 24
Overall Response Rate [Efficacy]
Month 24
Progression-free survival [Efficacy]
Month 24
Disease Control Rate [Efficacy]
Month 24
Percent Change in Tumor Size [Efficacy]

Trial Safety

Safety Progress

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

Similar Trials

1
Papaverine
1
PBF-1129
1
Durvalumab

Trial Design

3 Treatment Groups

Part 2, active treatment
1 of 3
Part 1, open label
1 of 3
Part 2, placebo
1 of 3

Experimental Treatment

Non-Treatment Group

192 Total Participants · 3 Treatment Groups

Primary Treatment: Part 2, active treatment · Has Placebo Group · Phase 2

Part 2, active treatmentExperimental Group · 3 Interventions: Pemetrexed, inupadenant, Carboplatin · Intervention Types: Drug, Drug, Drug
Part 1, open labelExperimental Group · 3 Interventions: Pemetrexed, inupadenant, Carboplatin · Intervention Types: Drug, Drug, Drug
Part 2, placeboPlaceboComparator Group · 3 Interventions: Pemetrexed, Placebo, Carboplatin · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5050
Carboplatin
2014
Completed Phase 3
~7230

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to death due to any cause, assessed up to 24 months.

Who is running the clinical trial?

iTeos Belgium SALead Sponsor
5 Previous Clinical Trials
868 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have measurable disease as defined by RECIST v1.1 criteria.
Expression of PD-L1 in the tumor or in the surrounding tissue.
You have adequate organ function.
References

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