Non-small Cell Lung CancerNCT01297101
Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy
A study testing Erlotinib in people with Non-small Cell Lung Cancer, run by Shanghai Chest Hospital.
Trial summary
The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed of non-small cell lung cancer
- Diagnosed as stage IIIA-NI, N2, except for T4N1M0
- The diagnosis standard of N1 or N2 is as below:
- The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be > 2.5
Who cannot join
- 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)
- Resection of primary malignancy
About this study
Official title: A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21
The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.
Read the detailed description
Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.
Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.
Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib
- 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.
ErlotinibDrug
Also called Tarceva
150mg/qd, on day 15-28 of each 28 day cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 Shanghai Chest HospitalThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297101
- Sponsor's protocol ID
- ML25268(C-TONG1101)
- Status last verified
- Jan 2011
- First submitted
- 15 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
Publications
Chen Z, Shen S, Shi W, Jiang G, Wang X, Jian H, Zhou Z, Ding Z, Lu S. Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study. Cancer Manag Res. 2019 Jul 12;11:6543-6552. doi: 10.2147/CMAR.S189287. eCollection 2019.
PubMed 31372055
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21
- ClinicalTrials.gov ID
- NCT01297101
- Acronym / sponsor ID
- ML25268(C-TONG1101)
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Shanghai Pulmonary Hospital, Shanghai, China
- First posted
- 16 Feb 2011 (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 aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.
Detailed description
Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.
Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.
Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically diagnosed of non-small cell lung cancer
- Diagnosed as stage IIIA-NI, N2, except for T4N1M0
- The diagnosis standard of N1 or N2 is as below:
- The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be > 2.5
Key exclusion criteria (3 listed)
- 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)
- Resection of primary malignancy
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 |
|---|---|---|
| ErlotinibAlso: Tarceva150mg/qd, on day 15-28 of each 28 day cycle. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
- Derived from this study: PubMed 31372055Chen Z, Shen S, Shi W, Jiang G, Wang X, Jian H, Zhou Z, Ding Z, Lu S. Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study. Cancer Manag Res. 2019 Jul 12;11:6543-6552. doi: 10.2147/CMAR.S189287. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Erlotinib in people with Non-small Cell Lung Cancer, run by Shanghai Chest Hospital.
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 4 inclusion and 3 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 16 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01297101, 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 Feb 2011.