Non Small Cell Lung CancerPhase 2NCT03374280
Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
A Phase 2 study testing pemetrexed/cisplatin intercalating gefitinib and pemetrexed/cisplatin in people with Non Small Cell Lung Cancer, run by Guangzhou Medical University at 1 site in China.
Trial summary
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC 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/cisplatin intercalating gefitinib and pemetrexed/cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 30 Dec 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
- 1.Histological or cytological diagnosis of small-cll lung cancer histology
- 2.18 years or older
- 3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- 4.Local stage SCLC without distant metastases
- 5.After 1st-line chemotherapy (EP or IP) at least 4 cycles
- 6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
Show all 10Show fewer
- 7.CR or PR assessment by RECIST(1.0) before randomized
- 8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- 9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- 10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Who cannot join
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, 510120
Haihong Yang, MD, 0862083062825, bjrf2009@yahoo.com
Haihong Yang, Dr.
About this study
Official title: The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
Read the detailed description
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- pemetrexed/cisplatin intercalating gefitinib, pemetrexed/cisplatin
- Keywords
- non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed
- 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.
pemetrexed/cisplatin intercalating gefitinibDrug
pemetrexed/cisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed/cisplatin intercalating gefitinib | Experimental | pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles.
pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable Receives: Drug: pemetrexed/cisplatin intercalating gefitinib |
| pemetrexed/cisplatin | Active comparator | pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable Receives: Drug: pemetrexed/cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression-free survival
the last patient into group for three years or dead
Measured: 3 years
Secondary outcomes (3)
overall survival
the last patients into group for 5 years or dead
Measured: 5 years
side-effects
the last patient into group for 3 years or dead
Measured: 3 years
overall response rate
the last patient into group for 3 years or dead
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2016
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
- Investigators
- Jiajia Yu, MD, Study director, the ethics committee of the first affiliated hospital of Guangzhou MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374280
- Sponsor's protocol ID
- GuangzhouMC
- Status last verified
- Mar 2019
- First submitted
- 11 Dec 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
- ClinicalTrials.gov ID
- NCT03374280
- Acronym / sponsor ID
- GuangzhouMC
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 15 Dec 2017 (actual)
- 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.
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
Detailed description
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pemetrexed/cisplatin intercalating gefitinib | Experimental | Drug: pemetrexed/cisplatin intercalating gefitinibpemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable |
| pemetrexed/cisplatin | Active comparator | Drug: pemetrexed/cisplatinpemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Histological or cytological diagnosis of small-cll lung cancer histology
- 2.18 years or older
- 3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- 4.Local stage SCLC without distant metastases
- 5.After 1st-line chemotherapy (EP or IP) at least 4 cycles
Key exclusion criteria (5 listed)
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women
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 |
|---|---|---|
| pemetrexed/cisplatin intercalating gefitinib | Drug | pemetrexed/cisplatin intercalating gefitinib |
| pemetrexed/cisplatin | Drug | pemetrexed/cisplatin |
Primary outcome
disease progression-free survival
Time frame: 3 years
the last patient into group for three years or dead
3 secondary outcomes
overall survival
Time frame: 5 years
side-effects
Time frame: 3 years
overall response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jiajia Yu, MD study director
the ethics committee of the first affiliated hospital of Guangzhou MC
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/cisplatin intercalating gefitinib and pemetrexed/cisplatin in people with Non Small Cell Lung Cancer, run by Guangzhou Medical University 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 10 inclusion and 5 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 28 Mar 2019. 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 Hailing Yang, MD (00862083062825, bjrf2009@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.