Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin for Non-Small Cell Lung Cancer

Research Site, Cordoba, Spain
Non-Small Cell Lung CancerOsimertinib (AZD9291) pemetrexed cisplatin or carboplatin - Drug
Eligibility
18 - 130
All Sexes

Study Summary

This trial will compare the efficacy of two types of chemotherapy treatments in patients who have progressed after taking osimertinib as their first line of treatment.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: At Screening,every 6 weeks for the first 13 cycles (each cycle is 21 days),then every 12 weeks, relative to randomization,and upto intracranial or extracranial disease progression or end of survival follow-up,whichever comes first (approximately 3 years)

Year 3
Extracranial PFS is defined as time from randomization until extracranial progression per RECIST 1.1 as assessed by the Investigator at local site or death due to any cause
Intracranial PFS is defined as time from randomization until intracranial progression per CNS RECIST 1.1 as assessed by the Investigator at local site or death due to any cause
OS: the length of time from randomization until the date of death due to any cause
Progression free survival (PFS): time from randomization until progression (intracranial or extracranial, whichever occurs first) per RECIST 1.1 (for extracranial progression) and CNS RECIST 1.1 (for intracranial progression)
Week 12
Number of patients with serious and non-serious adverse events

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Treatment Arm A
1 of 2
Treatment Arm B
1 of 2

Experimental Treatment

Non-Treatment Group

204 Total Participants · 2 Treatment Groups

Primary Treatment: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin · Has Placebo Group · Phase 3

Treatment Arm A
Drug
Experimental Group · 1 Intervention: Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin · Intervention Types: Drug
Treatment Arm B
Drug
PlaceboComparator Group · 1 Intervention: Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at screening,every 6 weeks for the first 13 cycles (each cycle is 21 days),then every 12 weeks, relative to randomization,and upto intracranial or extracranial disease progression or end of survival follow-up,whichever comes first (approximately 3 years)

Who is running the clinical trial?

ParexelIndustry Sponsor
286 Previous Clinical Trials
93,529 Total Patients Enrolled
AstraZenecaLead Sponsor
4,057 Previous Clinical Trials
240,403,720 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

What chemotherapy drugs has the FDA cleared Osimertinib (AZD9291) for use with?

"Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin has received a safety rating of 3. This is based off of the fact that this is a Phase 3 trial, which suggests that there is some evidence for efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

Is this research project actively recruiting new participants?

"The trial is still open for recruitment, as seen on clinicaltrials.gov. This specific study was originally posted on September 12th, 2021 and was edited on October 10th, 2022." - Anonymous Online Contributor

Unverified Answer

Are there other ongoing studies that are testing Osimertinib (AZD9291) in combination with pemetrexed, cisplatin or carboplatin?

"The original trial for Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin was at City of Hope Comprehensive Cancer Center in 1997. As of now, there have been a total of 1790 completed trials and 1306 active trials. Many of these active trials are being conducted in Boston, Minnesota." - Anonymous Online Contributor

Unverified Answer

How many participants are being included in this clinical trial?

"That is accurate. The clinical trial in question, which is looking for 204 participants at 4 locations, is actively recruiting patients according to the information available on clinicaltrials.gov. The trial was originally posted on September 12th, 2021 and was last edited on October 10th, 2022." - Anonymous Online Contributor

Unverified Answer

Does this experimental treatment only test on geriatric patients?

"According to the inclusion criteria posted for this clinical trial, eligible patients must be between 18 and 130 years old. There are 143 trials for patients under the age of 18 and 3206 for people over 65." - Anonymous Online Contributor

Unverified Answer

If I want to participate in this clinical trial, how many different city locations do I have to choose from?

"Currently, there are 4 enrolling sites for this study with more to come. The sites are situated in cities including Boston, Minneapolis and Silver Spring. If you enroll in the study, it is best to choose the clinic that is most convenient for you to reduce travel time and effort." - Anonymous Online Contributor

Unverified Answer

What type of cancer do doctors most often treat with Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin?

"Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin is most often used to treat lymphoma, non-hodgkin. However, it has also shown efficacy in the treatment of malignant neoplasms, advanced sarcoma, and neoplasm metastasis." - Anonymous Online Contributor

Unverified Answer

Might I be eligible to join this clinical trial?

"This study is for people with [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) who are 18 to 130 years old. There are 204 spots in the trial. To join, participants must: - Be male and willing to use contraception- Have a life expectancy of more than 12 weeks- Have stage IIIB or IIIC cancer that can't be cured with surgery or stage IVA or IVB cancer that has come back- Be in good enough health that they can take part in the trial- Be female and using contraception or not be able to have children" - 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.