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Monoclonal Antibodies

Osimertinib + Amivantamab for Lung Cancer (OSTARA Trial)

Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 lesion that can be accurately measured at baseline as ≥10 mm in the longest diameter with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements.
Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed)
Awards & highlights

OSTARA Trial Summary

This trial will test a new drug combo to treat advanced NSCLC caused by a gene mutation.

Who is the study for?
This trial is for adults with newly diagnosed or recurrent non-squamous Non-small Cell Lung Cancer (NSCLC) that can't be removed by surgery. Participants should have a life expectancy of more than 12 weeks, no prior advanced NSCLC treatment, and must not have certain health conditions like interstitial lung disease or heart problems.Check my eligibility
What is being tested?
The study tests the combination of Osimertinib and Amivantamab as a first-line treatment for NSCLC patients with specific EGFR mutations. It aims to evaluate the safety and effectiveness of this drug duo in managing locally advanced or metastatic cancer.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs' components, issues related to infusion such as fever or chills, lung problems like difficulty breathing, skin reactions, gastrointestinal disturbances like nausea or diarrhea, and possible liver enzyme changes.

OSTARA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a tumor that is at least 10 mm large and can be measured by CT or MRI.
Select...
My lung cancer cannot be cured with surgery or radiation.
Select...
My tumor has a mutation known to respond to certain lung cancer treatments.

OSTARA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first dose of study intervention until death due to any cause. landmarks at 18 and 24 months. (approximately 52 months after the first participant is dosed) 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 (AEs)
Progression Free Survival (PFS)
Secondary outcome measures
Duration of Response (DoR)
Objective Response Rate (ORR)
Overall Survival (OS)

OSTARA Trial Design

1Treatment groups
Experimental Treatment
Group I: Osimertinib+AmivantamabExperimental Treatment2 Interventions
Participants will receive osimertinib and amivantamab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,595 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,072 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct venues are managing this experiment?

"At present, this clinical trial is running across 24 sites located in Kuantan, Chiang Mai and Newmarket as well as 21 other cities. To reduce travel time for participants, it's suggested that they enrol at the closest clinic to their residence."

Answered by AI

Has the pairing of Osimertinib and Amivantamab obtained regulatory approval?

"As this is a Phase 2 clinical trial, there is evidence of safety yet no data indicating efficacy. Therefore, our team at Power have assigned the combination therapy of Osimertinib+Amivantamab a score of 2 on their scale from 1 to 3."

Answered by AI

Will elderly individuals be considered for inclusion in this research project?

"The inclusionary parameters of this trial necessitates that applicants must be aged between 18 and 130. Those younger than 18 can participate in 48 other trials, while those older than 65 have access to 2034 studies."

Answered by AI

How extensive is the present participation in this clinical research?

"Affirmative. Clinicaltrials.gov reflects that this research project, first announced on July 18th 2023, is actively seeking participants at present. 80 volunteers must be recruited from 24 distinct medical facilities."

Answered by AI

Is this clinical trial still recruiting participants?

"Citing clinicaltrials.gov, this trial is actively recruiting for participants. It was first advertised on July 18th 2023 and has undergone revision as recently as September 8th 2023."

Answered by AI

Are there any particular groups of individuals that are best suited for this research endeavor?

"The clinical trial is looking to enrol 80 individuals with non-squamous non-small cell lung cancer. Candidates must be between 18 and 130, have a World Health Organisation performance status of 0 or 1 (with no worsening prior to application), an expected lifespan longer than 12 weeks at Day 1, confirmation through laboratory tests that the tumour contains certain EGFR activating mutations associated with sensitivity to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, and a lesion measuring 10mm in longest diameter for accurate measurements. Applicants of both genders should adopt contraceptive methods appropriate under local regulations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations
2023. "A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epidermal Growth Factor Receptor Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801029.
~53 spots leftby Oct 2027
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