Chemotherapy for Chemotherapy

Research Site, Göteborg, Sweden
ChemotherapyChemotherapy - Drug
18 - 130
All Sexes

Study Summary

This trial is studying osimertinib vs platinum-based doublet chemotherapy to see if they are better in treating patients with non-small cell lung cancer whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy and whose tumors contain a T790M mutation.

Eligible Conditions
  • Chemotherapy

Treatment Effectiveness

Phase-Based Effectiveness

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

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary PFS analysis).

Month 43
Time to First Subsequent Therapy (TFST)
Time to Second Subsequent Therapy (TSST)
Month 43
Secondary: Overall Survival (OS)
Month 19
Disease Control Rate (DCR) by Investigator Assessment
Duration of Response (DoR) by Investigator Assessment
Objective Response Rate (ORR) by Investigator Assessment
Progression Free Survival (PFS) by Investigator Assessment
Tumour Shrinkage by Investigator Assessment

Trial Safety

Phase-Based Safety

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

Side Effects for

14%Alanine aminotransferase increased
14%White blood cell count decreased
10%Aspartate aminotransferase increased
10%Platelet count decreased
10%Neutrophil count decreased
5%Musculoskeletal pain
5%Back pain
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT02000531) in the Erlotinib-Chemotherapy ARM group. Side effects include: Nausea with 29%, Leukopenia with 19%, Vomiting with 14%, Neutropenia with 14%, Alanine aminotransferase increased with 14%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Platinum-based doublet chemotherapy
1 of 2
1 of 2

Active Control

Experimental Treatment

419 Total Participants · 2 Treatment Groups

Primary Treatment: Chemotherapy · No Placebo Group · Phase 3

OsimertinibExperimental Group · 2 Interventions: Cross-over to Osimertinib, Chemotherapy · Intervention Types: Drug, Drug
Platinum-based doublet chemotherapy
ActiveComparator Group · 1 Intervention: Chemotherapy · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: recist tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of the primary pfs analysis).

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,057 Previous Clinical Trials
240,403,505 Total Patients Enrolled
Yilong Wu, MDPrincipal InvestigatorGuangdong General Hospital, Guangdong, 510030, China
12 Previous Clinical Trials
2,053 Total Patients Enrolled
Vassiliki A Papadimitrakopoulou, MDPrincipal InvestigatorThe University of Texas/M.D. Anderson Cancer Center, Houston, Tx, USA

Eligibility Criteria

Age 18 - 130 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have non-small cell lung cancer that has spread to other parts of your body or is too advanced to be treated with surgery or radiation.
You are able to receive the specific chemotherapy treatment being used in the study.
You have a new growth or tumor that has not been treated with radiation before.

Frequently Asked Questions

Does the FDA endorse chemotherapy as an effective cancer treatment?

"Chemotherapy, while not without its risks, has received a score of 3 because of the available data supporting its efficacy and safety." - Anonymous Online Contributor

Unverified Answer

Are there certain ineligibilities which would preclude an individual from joining this research project?

"The requirements to participate in this study are that patients have a diagnosis of lung cancer and are between 18-130 years old. The goal is to enroll 419 patients in total." - Anonymous Online Contributor

Unverified Answer

Does this study have a wide reach in terms of the number of participating clinics?

"There are 27 total active sites for this trial, which are situated in cities like Houston, Gainesville and Charleston. If you enroll in the study, choosing a location nearest to you will help reduce travel-related burden." - Anonymous Online Contributor

Unverified Answer

What other treatments have been studied that use Chemotherapy?

"The first chemotherapy trials were conducted in 2002 at the Department of Radiation Oncology in the National Cancer Center. As of today, there have been a total of 267 active studies, with a large portion of these ongoing clinical trials taking place in Houston, Texas." - Anonymous Online Contributor

Unverified Answer

Are there any participants currently needed for this experiment?

"As of now, this trial has paused recruitment. The study was first posted on 8/4/2014 and was most recently updated on 10/26/2022. However, if you are looking for other studies, there are presently 1940 studies actively enrolling participants with lung cancer and 267 trials for Chemotherapy that are still recruiting patients." - Anonymous Online Contributor

Unverified Answer

For this particular research project, are volunteers of all ages being accepted?

"According to the enrollment requirements for this clinical trial, individuals must be aged 18 or older but not 130 years old or above." - Anonymous Online Contributor

Unverified Answer

Could you share how many people are taking part in this experiment?

"Unfortunately, this clinical trial is not recruiting patients at the moment. Though, it is worth noting that the study was most recently updated on October 26th, 2022. For those searching for other studies, there are 1940 clinical trials actively enrolling participants with lung cancer and 267 clinical trials for Chemotherapy actively enrolling participants." - 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.