Non-small Cell Lung CancerPhase 2NCT02725918
Pemetrexed vs Pemetrexed Plus Cisplatin in EGFR-mutant NSCLC Patients After First Line EGFR-TKIs Failure
A Phase 2 study testing Pemetrexed and Cisplatin in people with Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. The investigators hope to figure out the better chemotherapy regimen for the post-EGFR-TKI failure setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Pemetrexed and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2016to Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent must be signed.
- Age of ≥18 and < 75 years old.
- Performance status (PS) 0 - 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Histologically confirmed stage IIIB/IV advanced NSCLC harboring activating EGFR mutation.
- Chemotherapy-naïve for advanced disease.
- Acquired resistance is measured according to the Jackman criteria. Achieved complete remission (CR)/partial remission (PR)≥4 months or stable disease (SD)>6 months with first-line EGFR TKIs (Gefitinib or Erlotinib or Icotinib) for advanced NSCLC.
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- Disease progression(RECIST) <4 weeks prior to study randomization.
- Adequate organ function including the following:
- Bone marrow: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelets ≥100 x 109/L hemoglobin ≥9 g/dL.
- Hepatic: total bilirubin ≤1.5 times the upper limit of normal (ULN), liver transaminases: aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) ≤2.5 times ULN. AST and ALT ≤ 5 x ULN may be included only if Patient has liver metastasis.
- Renal: calculated creatinine clearance ≥45 mL/min (using the standard Cockcroft-Gault formula).
- Patients have resolution to <Grade 2 by the CTCAE (Version 4.0), of all clinically significant toxic effects of prior anti-cancer therapy (with the exception of rash and alopecia).
- Patients with stable central nervous system (CNS) metastasis successfully treated with local therapy, or with asymptomatic CNS metastasis are eligible. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for ≥2 weeks and off of corticosteroids for ≥1 week.
- At least one measurable lesion as defined by RECIST 1.1 criteria.
- Previous palliative radiation therapy is allowed, but limited in <25% of the bone marrow and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed one month before study entry. Radiotherapy should not be administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented.
- Estimated life expectancy of at least 8 weeks.
- For women: must be surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 3 months after the treatment period; must not be pregnant and must not be lactating; negative pregnancy test is required for women of childbearing potential. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. For men: must be surgically sterile or compliant with a highly effective contraceptive method during and for 3 months after the treatment period.
- Patient compliance and geographic proximity that allow adequate follow-up. Willingness to provide blood samples for EGFR mutation test at baseline and disease progression.
Who cannot join
- Patient got disease relapsed within 12 months after post-operative adjuvant chemotherapy, thereafter got failure from subsequent EGFR-TKI treatment cannot be enrolled.
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis \& T1].
- Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that will compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Significant cardiovascular event: congestive heart failure >New York Heart Association (NYHA) class 2; unstable angina, active coronary artery disease (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of significant neurological or mental disorder, including seizures or dementia.
- Incision from operation has not healed before the start of study treatment (Small incision for biopsy is eligible.)
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- Presence of clinically uncontrollable third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Inability or unwillingness to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) from 2 days before to 2 days after administration of pemetrexed. If a patient is taking an NSAID (including Cox-2 inhibitors) or salicylate with a long half-life (e.g. naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib), it should not be taken from 5 days before to 2 days after the administration of pemetrexed.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone.
- Inability to comply with protocol or study procedures.
- Concurrent use of any other anti-tumor therapy during study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Lung cancer institute
Guangzhou, Guangdong, 510080
Qing Zhou, MD, 86 13544561166, gzzhouqing@126.com
About this study
Official title: Randomized Phase II Study of Pemetrexed Alone vs Pemetrexed Plus Cisplatin in Patients With EGFR Mutation-positive Advanced NSCLC After First Line EGFR-TKIs Failure
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. The investigators hope to figure out the better chemotherapy regimen for the post-EGFR-TKI failure setting. The primary objective of this trial is to compare progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and single-agent pemetrexed treatment arms.
The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.
Read the detailed description
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
The trial will include stage IIIB/IV EGFR activating mutation positive NSCLC patients who got disease progression after frontline EGFR-TKI treatment. Clinical staging is determined according to the routine protocol, which includes enhanced chest CT scans, abdominal ultrasonography or CT scans, brain MRI or CT, and bone scintigraphy. Positron emission tomography (PET)/CT scan is optional. Measurement of acquired resistance to EGFR-TKIs is based on Jackman criteria.
Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities. All patients will be administrated with vitamin B12 and folic acid supplement (vitamin B12 1mg intramuscular injection at least 7 days prior to the first dose of pemetrexed and repeated approximately every 9 weeks during pemetrexed treatment till 22 days after the last dose of pemetrexed; folic acid 0.5 mg orally administered once daily from at least 7 days prior to the first dose of pemetrexed till 22 days after the last dose of pemetrexed).
Efficacy data will be analyzed by intention-to-treat (ITT) population using all randomized patients, and safety data will be evaluated using CTCAE v4.0 criteria for patients who received ≥ 1 dose of study treatment. If the criteria for drug administration (absolute neutrophil count ≥1500/μl, platelets ≥100 000/μl, creatinine clearance ≥45 ml/min, no grade ≥3 nonhematologic toxicity [except for alopecia]) were not met, drug administration have to be delayed to allow sufficient time for recovery. If a delay of more than 42 days due to toxicity was necessary, the patient will be discontinued from the study. Dose adjustments according to hematologic toxicity at the start of a subsequent cycle of the therapy will be based on platelet and neutrophil nadir counts from the preceding cycle. Granulocyte colony-stimulating factor is allowed to use for neutropenia event. Patients will be discontinued from study treatment for the following reasons: disease progression; unacceptable toxicities; patient's refusal to continue.
Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months.
Blood samples [8ml with ehylene diamine tetraacetic acid (EDTA) as anticoagulant each time] will be collected at the time of baseline, tumor response evaluation every 2 cycles, and disease progression. Blood samples at baseline and disease progression are mandatory to be provided. Tumor samples collection at the time of baseline and/or disease progression is strongly recommended but not mandatory for this study.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pemetrexed, Cisplatin
- Keywords
- NSCLC, EGFR-TKI failure, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta，pemetrexed disodium
500 mg/m2,iv,d1,q3w,until PD
CisplatinDrug
Also called DDP，platinol
75 mg/m2,iv,d1,q3w,×4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Pem mono | Experimental | Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities. Receives: Drug: Pemetrexed |
| Pem+Cis | Active comparator | Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Receives: Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival without grade 4 (G4PFS)
Measured: From the date of randomization to the earliest occurrence of the first of grade 4 adverse events (AEs), disease progression, or death from any cause, regardless of whether or not the event leads to discontinuation,assessed up to 4 months.
Secondary outcomes (3)
Progression free survival (PFS)
Measured: From the date of randomization to the first date of documented objective progression disease or of death from any cause,assessed up to 6 months.
Overall survival (OS)
Measured: From the date of randomization to the date of death from any cause,assessed up to 12 months.
Overall response rate (ORR)
Measured: From randomization to date of objective disease progression,assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi long Wu, Principal investigator, Guangzhou lung cancer institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725918
- Sponsor's protocol ID
- CTONG1510
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Zeng Z, Yan HH, Zhang XC, Zhong WZ, He YY, Guan JL, Niu FY, Xie Z, Huang YS, Xu CR, Dong S, Wu YL. Reduced chemotherapy sensitivity in EGFR-mutant lung cancer patient with frontline EGFR tyrosine kinase inhibitor. Lung Cancer. 2014 Nov;86(2):219-24. doi: 10.1016/j.lungcan.2014.09.008. Epub 2014 Sep 18.
PubMed 25263853Tseng JS, Yang TY, Chen KC, Hsu KH, Yu CJ, Liao WY, Tsai CR, Tsai MH, Yu SL, Su KY, Chen JJ, Chen HY, Chang GC. Prior EGFR tyrosine-kinase inhibitor therapy did not influence the efficacy of subsequent pemetrexed plus platinum in advanced chemonaive patients with EGFR-mutant lung adenocarcinoma. Onco Targets Ther. 2014 May 23;7:799-805. doi: 10.2147/OTT.S62639. eCollection 2014.
PubMed 24920920Yang JJ, Chen HJ, Yan HH, Zhang XC, Zhou Q, Su J, Wang Z, Xu CR, Huang YS, Wang BC, Yang XN, Zhong WZ, Nie Q, Liao RQ, Jiang BY, Dong S, Wu YL. Clinical modes of EGFR tyrosine kinase inhibitor failure and subsequent management in advanced non-small cell lung cancer. Lung Cancer. 2013 Jan;79(1):33-9. doi: 10.1016/j.lungcan.2012.09.016. Epub 2012 Oct 15.
PubMed 23079155Zinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366.
PubMed 25371077
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Pemetrexed Alone vs Pemetrexed Plus Cisplatin in Patients With EGFR Mutation-positive Advanced NSCLC After First Line EGFR-TKIs Failure
- ClinicalTrials.gov ID
- NCT02725918
- Acronym / sponsor ID
- CTONG1510
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, EGFR-TKI failure, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial. The investigators hope to figure out the better chemotherapy regimen for the post-EGFR-TKI failure setting. The primary objective of this trial is to compare progression-free survival without grade 4 (G4PFS) toxicities between pemetrexed-cisplatin and single-agent pemetrexed treatment arms.
The trial will include stage IIIB/IV EGFR mutation positive NSCLC patients who got disease progression after front-line EGFR TKI treatment.Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities.
Detailed description
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
The trial will include stage IIIB/IV EGFR activating mutation positive NSCLC patients who got disease progression after frontline EGFR-TKI treatment. Clinical staging is determined according to the routine protocol, which includes enhanced chest CT scans, abdominal ultrasonography or CT scans, brain MRI or CT, and bone scintigraphy. Positron emission tomography (PET)/CT scan is optional. Measurement of acquired resistance to EGFR-TKIs is based on Jackman criteria.
Eligible patients will be randomized to 2 arms. Patients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. Patients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities. All patients will be administrated with vitamin B12 and folic acid supplement (vitamin B12 1mg intramuscular injection at least 7 days prior to the first dose of pemetrexed and repeated approximately every 9 weeks during pemetrexed treatment till 22 days after the last dose of pemetrexed; folic acid 0.5 mg orally administered once daily from at least 7 days prior to the first dose of pemetrexed till 22 days after the last dose of pemetrexed).
Efficacy data will be analyzed by intention-to-treat (ITT) population using all randomized patients, and safety data will be evaluated using CTCAE v4.0 criteria for patients who received ≥ 1 dose of study treatment. If the criteria for drug administration (absolute neutrophil count ≥1500/μl, platelets ≥100 000/μl, creatinine clearance ≥45 ml/min, no grade ≥3 nonhematologic toxicity [except for alopecia]) were not met, drug administration have to be delayed to allow sufficient time for recovery. If a delay of more than 42 days due to toxicity was necessary, the patient will be discontinued from the study. Dose adjustments according to hematologic toxicity at the start of a subsequent cycle of the therapy will be based on platelet and neutrophil nadir counts from the preceding cycle. Granulocyte colony-stimulating factor is allowed to use for neutropenia event. Patients will be discontinued from study treatment for the following reasons: disease progression; unacceptable toxicities; patient's refusal to continue.
Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months.
Blood samples [8ml with ehylene diamine tetraacetic acid (EDTA) as anticoagulant each time] will be collected at the time of baseline, tumor response evaluation every 2 cycles, and disease progression. Blood samples at baseline and disease progression are mandatory to be provided. Tumor samples collection at the time of baseline and/or disease progression is strongly recommended but not mandatory for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pem mono | Experimental | Drug: PemetrexedPatients in arm B will receive pemetrexed (500 mg/m2, d1) every 3 weeks until PD or intolerable toxicities. |
| Pem+Cis | Active comparator | Drug: Pemetrexed, Drug: CisplatinPatients in arm A will receive 4 cycles of cisplatin (75 mg/m2, d1) and pemetrexed (500 mg/m2, d1) every 3 weeks, those without disease progression (PD) and being tolerable judged by investigator will continue single-agent pemetrexed (500 mg/m2, d1) every 3 weeks as maintenance until progression or intolerable toxicities. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Informed consent must be signed.
- Age of ≥18 and < 75 years old.
- Performance status (PS) 0 - 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- Histologically confirmed stage IIIB/IV advanced NSCLC harboring activating EGFR mutation.
- Chemotherapy-naïve for advanced disease.
Key exclusion criteria (11 listed)
- Patient got disease relapsed within 12 months after post-operative adjuvant chemotherapy, thereafter got failure from subsequent EGFR-TKI treatment cannot be enrolled.
- History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis \& T1].
- Any unstable systemic disease (including active infection, hepatic, renal or metabolic disease) or serious concomitant disorders that will compromise the safety of the patient, or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Significant cardiovascular event: congestive heart failure >New York Heart Association (NYHA) class 2; unstable angina, active coronary artery disease (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of significant neurological or mental disorder, including seizures or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimta，pemetrexed disodium500 mg/m2,iv,d1,q3w,until PD | Drug | Pem mono, Pem+Cis |
| CisplatinAlso: DDP，platinol75 mg/m2,iv,d1,q3w,×4 cycles | Drug | Pem+Cis |
Primary outcome
Progression-free survival without grade 4 (G4PFS)
Time frame: From the date of randomization to the earliest occurrence of the first of grade 4 adverse events (AEs), disease progression, or death from any cause, regardless of whether or not the event leads to discontinuation,assessed up to 4 months.
3 secondary outcomes
Progression free survival (PFS)
Time frame: From the date of randomization to the first date of documented objective progression disease or of death from any cause,assessed up to 6 months.
Overall survival (OS)
Time frame: From the date of randomization to the date of death from any cause,assessed up to 12 months.
Overall response rate (ORR)
Time frame: From randomization to date of objective disease progression,assessed up to 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Results publication: PubMed 25263853Zeng Z, Yan HH, Zhang XC, Zhong WZ, He YY, Guan JL, Niu FY, Xie Z, Huang YS, Xu CR, Dong S, Wu YL. Reduced chemotherapy sensitivity in EGFR-mutant lung cancer patient with frontline EGFR tyrosine kinase inhibitor. Lung Cancer. 2014 Nov;86(2):219-24. doi: 10.1016/j.lungcan.2014.09.008. Epub 2014 Sep 18.
- Results publication: PubMed 24920920Tseng JS, Yang TY, Chen KC, Hsu KH, Yu CJ, Liao WY, Tsai CR, Tsai MH, Yu SL, Su KY, Chen JJ, Chen HY, Chang GC. Prior EGFR tyrosine-kinase inhibitor therapy did not influence the efficacy of subsequent pemetrexed plus platinum in advanced chemonaive patients with EGFR-mutant lung adenocarcinoma. Onco Targets Ther. 2014 May 23;7:799-805. doi: 10.2147/OTT.S62639. eCollection 2014.
- Results publication: PubMed 23079155Yang JJ, Chen HJ, Yan HH, Zhang XC, Zhou Q, Su J, Wang Z, Xu CR, Huang YS, Wang BC, Yang XN, Zhong WZ, Nie Q, Liao RQ, Jiang BY, Dong S, Wu YL. Clinical modes of EGFR tyrosine kinase inhibitor failure and subsequent management in advanced non-small cell lung cancer. Lung Cancer. 2013 Jan;79(1):33-9. doi: 10.1016/j.lungcan.2012.09.016. Epub 2012 Oct 15.
- Results publication: PubMed 25371077Zinner RG, Obasaju CK, Spigel DR, Weaver RW, Beck JT, Waterhouse DM, Modiano MR, Hrinczenko B, Nikolinakos PG, Liu J, Koustenis AG, Winfree KB, Melemed SA, Guba SC, Ortuzar WI, Desaiah D, Treat JA, Govindan R, Ross HJ. PRONOUNCE: randomized, open-label, phase III study of first-line pemetrexed + carboplatin followed by maintenance pemetrexed versus paclitaxel + carboplatin + bevacizumab followed by maintenance bevacizumab in patients ith advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Jan;10(1):134-42. doi: 10.1097/JTO.0000000000000366.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi long Wu principal investigator
Guangzhou lung cancer institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed and Cisplatin in people with Non-small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Zhou, MD (86 13544561166, gzzhouqing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival without grade 4 (G4PFS) (time frame: From the date of randomization to the earliest occurrence of the first of grade 4 adverse events (AEs), disease progression, or death from any cause, regardless of whether or not the event leads to discontinuation,assessed up to 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725918, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.