Lung CancerPhase 2NCT02428764
Neoadjuvant Nimotuzumab Plus Gemcitabine and Carboplatin in Unresectable Stage III Squamous Cell Lung Carcinoma
A Phase 2 study testing Nimotuzumab, Gemcitabine and Carboplatin in people with Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nimotuzumab, Gemcitabine and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to 1 Oct 2027
- 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
- Target population is unresectable stage III squamous cell lung carcinoma.
- Written informed consent provided.
- Male and female patients aged ≥18 years, ≤75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Life expectancy ≥12 weeks.
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- Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
- Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
- Female subjects should not be pregnant or breast-feeding.
Who cannot join
- Known severe hypersensitivity to nimotuzumab or any of the excipients of this product.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
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- Patients with prior radiotherapy
- History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
- Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
- Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Phase II Trial of Induction Nimotuzumab Plus Gemcitabine and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Squamous Cell Lung Carcinoma
The purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.
Read the detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Nimotuzumab, a human anti-EGFR monoclonal antibody, has shown its efficacy in the treatment of head/neck squamous cell carcinoma, nasopharyngeal carcinoma as well as lung cancer. This study is studying neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.
- Conditions
- Lung Cancer
- Being tested
- Nimotuzumab, Gemcitabine, Carboplatin, Surgery
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
Nimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8
GemcitabineDrug
Also called Gemzar
Gemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8.
CarboplatinDrug
Also called CBP
carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1.
SurgeryProcedure or surgery
Patients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery. Receives: Drug: Nimotuzumab; Drug: Gemcitabine; Drug: Carboplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
Measured: 3 months
Secondary outcomes (3)
Number of participants with perioperative complications
Measured: 1 year
Event-free survival
Event-free survival was assessed from diagnosis to disease recurrence/metastasis/progression or death as a result of any cause.
Measured: 2 years after the last patient is enrolled
Overall survival
Overall survival was assessed from diagnosis to death as a result of any cause.
Measured: 2 years after the last patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Why it stopped: No patients enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Si-Yu Wang, MD, Principal investigator, Guangdong Province Association Study of Thoracic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428764
- Sponsor's protocol ID
- GASTO1010
- Other IDs
- wsy006
- Status last verified
- Dec 2024
- First submitted
- 21 Apr 2015
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Trial of Induction Nimotuzumab Plus Gemcitabine and Carboplatin Followed by Surgery in Patients With Unresectable Stage III Squamous Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT02428764
- Acronym / sponsor ID
- GASTO1010
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 Apr 2015 (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 purpose of this study is studying induction nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.
Detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Nimotuzumab, a human anti-EGFR monoclonal antibody, has shown its efficacy in the treatment of head/neck squamous cell carcinoma, nasopharyngeal carcinoma as well as lung cancer. This study is studying neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery to see how well it works in treating patients with unresectable stage III squamous cell lung carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Nimotuzumab, Drug: Gemcitabine, Drug: Carboplatin, Procedure: SurgeryPatients were assigned to receive neoadjuvant nimotuzumab plus gemcitabine and carboplatin followed by surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Target population is unresectable stage III squamous cell lung carcinoma.
- Written informed consent provided.
- Male and female patients aged ≥18 years, ≤75 years.
- Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (11 listed)
- Known severe hypersensitivity to nimotuzumab or any of the excipients of this product.
- Inability to comply with protocol or study procedures.
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
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 |
|---|---|---|
| NimotuzumabNimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8 | Drug | Intervention group |
| GemcitabineAlso: GemzarGemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8. | Drug | Intervention group |
| CarboplatinAlso: CBPcarboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1. | Drug | Intervention group |
| SurgeryPatients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists. | Procedure or surgery | Intervention group |
Primary outcome
Resectability rate
Time frame: 3 months
3 secondary outcomes
Number of participants with perioperative complications
Time frame: 1 year
Event-free survival
Time frame: 2 years after the last patient is enrolled
Overall survival
Time frame: 2 years after the last patient is enrolled
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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.
Si-Yu Wang, MD principal investigator
Guangdong Province Association Study of Thoracic Oncology
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 Nimotuzumab, Gemcitabine and Carboplatin in people with Lung Cancer, run by Sun Yat-sen 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 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: withdrawn, as of the sponsor's last update on 10 Dec 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Resectability rate (time frame: 3 months). 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 10 Dec 2024.