Non-small Cell Lung CancerPhase 2AP/GPNCT01194453

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

A Phase 2 study testing cisplatin, dexamethasone,vitamin B12, folic acid and cisplatin, gemcitabine in people with Non-small Cell Lung Cancer and Efficacy, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-small Cell Lung Cancer, Efficacy
What is being tested?: cisplatin, dexamethasone,vitamin B12, folic acid and cisplatin, gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteChina
Study dates: Nov 2009to Aug 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
with an Eastern CooperativeOncology Group performance status of 0 or 1,
At least 18 years of age
adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
patients had fully recovered from its acute effects.

Who cannot join

peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
progressive brain metastases,
uncontrolled third-space fluid retention before study entry.
Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study

Conditions: Non-small Cell Lung Cancer, Efficacy
Being tested: cisplatin, dexamethasone,vitamin B12, folic acid, cisplatin, gemcitabine
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.

cisplatin, dexamethasone,vitamin B12, folic acidDrug
Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
cisplatin, gemcitabineDrug
cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

Study groups in NCT01194453
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Drug: cisplatin, dexamethasone,vitamin B12, folic acid
Group B	Active comparator	Not described Receives: Drug: cisplatin, gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
Measured: 36months

Secondary outcomes (1)

Response Rate
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Aug 2012

First posted3 Sep 2010 (estimated)
Study startNov 2009
Primary completionSep 2010
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01194453
Sponsor's protocol ID: HANSOH20090601
Acronym: AP/GP
Status last verified: May 2016
First submitted: 25 Aug 2010
Last updated: 16 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Huang Y, Liu Y, Zhou J, Xu N, Li B, Wu G, Fang J, Li K, Liu X, Liu W, Lu Y, Wang M, Liu W, Liang H, Zhang Y, Huang C, Wang S, Wang Y, Yu S, Chang J, Wang Z, Hu Z, Zhang L. [A randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gemcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2012 Oct;15(10):576-82. doi: 10.3779/j.issn.1009-3419.2012.10.03. Chinese.
PubMed 23075681

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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All Non-small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study
ClinicalTrials.gov ID: NCT01194453
Acronym / sponsor ID: AP/GP / HANSOH20090601
Conditions: Non-small Cell Lung Cancer, Efficacy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: Nov 2009
Primary completion: Sep 2010 (actual)
Study completion: Aug 2012 (actual)
First posted: 3 Sep 2010 (estimated)
Results: Posted 16 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: cisplatin, dexamethasone,vitamin B12, folic acid
Group B	Active comparator	Drug: cisplatin, gemcitabine

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
with an Eastern CooperativeOncology Group performance status of 0 or 1,
At least 18 years of age
adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.

Key exclusion criteria (4 listed)

peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
progressive brain metastases,
uncontrolled third-space fluid retention before study entry.
Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.

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
cisplatin, dexamethasone,vitamin B12, folic acidPatients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment	Drug	Group A
cisplatin, gemcitabinecisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8	Drug	Group B

Primary outcome

Progression Free Survival (PFS)
Time frame: 36months

1 secondary outcome

Response Rate
Time frame: 6 weeks

Results and safety

Results posted to the registry on 16 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	144	127
Group B	144	127

Primary outcome: Progression Free Survival (PFS)

Time frame: 36months. Median (95% Confidence Interval). Unit: day

Measure	Group A n = 144	Group B n = 144
Value	168 (139 to 183)	140 (113 to 164)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the delivery of the study drug to 21 days post the last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	5 of 144 (3.5%)	131 of 144 (91%)	Not reported
Group B	5 of 144 (3.5%)	140 of 144 (97.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23075681Huang Y, Liu Y, Zhou J, Xu N, Li B, Wu G, Fang J, Li K, Liu X, Liu W, Lu Y, Wang M, Liu W, Liang H, Zhang Y, Huang C, Wang S, Wang Y, Yu S, Chang J, Wang Z, Hu Z, Zhang L. [A randomized, controlled, multicenter clinical trial comparing pemetrexed/cisplatin and gemcitabine/cisplatin as first-line treatment for advanced nonsquamous non-small cell lung cancer]. Zhongguo Fei Ai Za Zhi. 2012 Oct;15(10):576-82. doi: 10.3779/j.issn.1009-3419.2012.10.03. Chinese.

Related trials for Non-small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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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.

Li Zhang, MD study chair

Cancer Center of Sun Yat-Sen University (CCSU)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jun 2016. 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?

Yes. Results are posted in the registry (first posted 16 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 36months). 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 NCT01194453, which also lists 1 linked publication.

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 16 Jun 2016.