AZD2936 for Non-Small Cell Lung Cancer

Research Site, Rio de Janeiro, Brazil
Non-Small Cell Lung CancerAZD2936 - Drug
Eligibility
18 - 130
All Sexes

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective for people with lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

3 Primary · 11 Secondary · Reporting Duration: Part B, C: From first dose of AZD2936 to PD or death in the absence of disease progression (approximately 2 years). Part D: From randomization to PD or death in the absence of disease progression (approximately 2 years).

Year 2
Incidence of anti-drug antibodies (ADA) against AZD2936 in serum
PK of AZD2936: Area under the concentration-time curve (AUC)
PK of AZD2936: Clearance
PK of AZD2936: Maximum plasma concentration of the study drug (Cmax)
PK of AZD2936: Terminal elimination half-life (t 1/2)
Year 2
Durable response rate (DRR)
Duration of response (DoR)
Month 6
Rate of AZD2936 discontinuation due to toxicity
Day 90
Percentage of participants with adverse events (AEs) and immune mediated AEs (imAEs), serious AEs (SAEs), dose limiting toxicities (DLTs), vital signs, and abnormal laboratory parameters
Year 2
Disease control rate (DCR)
Year 2
Measure the receptor occupancy (RO) of TIGIT and PD-1 on peripheral blood
Year 2
ORR
Year 2
Objective Response Rate (ORR)
Year 2
Progression-free survival (PFS)

Trial Safety

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

5 Treatment Groups

Dose Expansion Part C: CPI Naive NSCLC
1 of 5
Dose Expansion Part D: To be confirmed through a protocol amendment
1 of 5
Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced NSCLC
1 of 5
Dose Expansion Part D: CPI Naive NSCLC
1 of 5
Dose Expansion Part B: CPI experienced NSCLC
1 of 5

Experimental Treatment

192 Total Participants · 5 Treatment Groups

Primary Treatment: AZD2936 · No Placebo Group · Phase 1 & 2

Dose Expansion Part C: CPI Naive NSCLC
Drug
Experimental Group · 1 Intervention: AZD2936 · Intervention Types: Drug
Dose Expansion Part D: To be confirmed through a protocol amendment
Drug
Experimental Group · 1 Intervention: AZD2936 · Intervention Types: Drug
Dose Escalation Part A: Checkpoint inhibitor (CPI) experienced NSCLC
Drug
Experimental Group · 1 Intervention: AZD2936 · Intervention Types: Drug
Dose Expansion Part D: CPI Naive NSCLC
Drug
Experimental Group · 1 Intervention: AZD2936 · Intervention Types: Drug
Dose Expansion Part B: CPI experienced NSCLC
Drug
Experimental Group · 1 Intervention: AZD2936 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: part b, c: from first dose of azd2936 to pd or death in the absence of disease progression (approximately 2 years). part d: from randomization to pd or death in the absence of disease progression (approximately 2 years).

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,057 Previous Clinical Trials
240,403,732 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 12 more weeks at the time of enrollment.
References

Frequently Asked Questions

What is the current sample size for participants in this trial?

"Affirmative, the current status of the study according to clinicaltrials.gov is actively recruiting participants. This medical research was initially presented on September 14th 2021 and has since been updated as recent as November 16th 2022. A total of 147 individuals are expected to be recruited from 4 distinct sites." - Anonymous Online Contributor

Unverified Answer

Are there any unfilled opportunities for patients to join this clinical trial?

"Clinicaltrials.gov reveals that this clinical trial is currently enrolling patients, having first been listed on September 14th 2021 and most recently updated November 16th 2022." - Anonymous Online Contributor

Unverified Answer

What is the goal of this scientific investigation?

"The primary endpoint of this clinical trial, which is expected to last for around two years, will measure the rate at which patients discontinue AZD2936 due to toxicity. Secondary objectives include analysis of the drug's pharmacokinetic clearance, objective response rate (ORR), and progression-free survival (PFS)." - Anonymous Online Contributor

Unverified Answer

Which demographic is ideal for inclusion in the trial?

"To qualify for this clinical trial, patients are required to have nsclc and be between 18-130 years old. An approximate total of 147 individuals need to partake in the study." - Anonymous Online Contributor

Unverified Answer

Does this trial include individuals aged 65 and above?

"This medical trial is seeking to enrol individuals aged 18 or above, but not exceeding 130 years old." - Anonymous Online Contributor

Unverified Answer

In what ways is this experiment being administered across multiple facilities?

"Presently, 4 centres are enrolling participants in this clinical trial. These sites can be found across Rochester, Chicago and Orange as well as a few other areas. It is best to select the closest medical centre to avoid any unnecessary travel if accepted into the scheme." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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