Non Small Cell Lung Cancer
Conditions
Brief summary
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.
Interventions
DRUGgemcitabine
1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5)
DRUGcisplatin
80 mg/m2, IV, every 21 days x 5 cycles
RADIATIONradiation
63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inoperable non small cell lung cancer Stage III * Adequate hematological parameters * Adequate Lung function reserve
Exclusion criteria
* Previous chemotherapy and thoracic radiation for non small cell lung cancer * Presence of distant metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response at End of Treatment | baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation) | Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progressive Disease | Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years); | Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included. |
| Overall Survival | Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years) | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. |
| Safety of Induction Chemotherapy | every cycle (21 days) for 3 cycles (up to 10 weeks) | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening. |
| Safety of Chemo-radiotherapy | Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening. |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine + Cisplatin Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).
Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Clinical Disease Progression | 1 |
| Overall Study | Death | 1 |
| Overall Study | Objective Tumor Progression | 4 |
| Overall Study | Patient/Physician Perception | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Unknown or Not Specified | 5 |
Baseline characteristics
| Characteristic | Gemcitabine + Cisplatin |
|---|---|
| Age Continuous | 63.1 years STANDARD_DEVIATION 8.41 |
| Basis for Pathological Diagnosis Cytological | 10 participants |
| Basis for Pathological Diagnosis Histopathological | 39 participants |
| Disease Stage Stage IIIA | 14 participants |
| Disease Stage Stage IIIB | 35 participants |
| Karnofsky Performance Status Scale 100 - Normal no complaints; no evidence of disease | 16 participants |
| Karnofsky Performance Status Scale 80 - Activity with effort; some signs of disease | 9 participants |
| Karnofsky Performance Status Scale 90 - Normal activity; minor signs of disease | 24 participants |
| Pathological Diagnosis Adenocarcinoma of Lung | 18 participants |
| Pathological Diagnosis Large Cell | 7 participants |
| Pathological Diagnosis Other Pathological Diagnosis | 2 participants |
| Pathological Diagnosis Squamous Cell | 22 participants |
| Region of Enrollment Belgium | 49 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 36 Participants |
| Time Since Diagnosis | 0.5 months STANDARD_DEVIATION 0.25 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 49 |
| serious Total, serious adverse events | 13 / 49 |
Outcome results
Primary
Tumor Response at End of Treatment
Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time frame: baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Complete Response | 1 participants |
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Partial Response | 18 participants |
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Stable Disease | 3 participants |
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Progressive Disease | 1 participants |
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Unknown | 22 participants |
| Gemcitabine + Cisplatin | Tumor Response at End of Treatment | Missing | 4 participants |
Secondary
Overall Survival
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Time frame: Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years)
Population: All enrolled participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Overall Survival | Preliminary | 27.9 months |
| Gemcitabine + Cisplatin | Overall Survival | Final | 21.8 months |
Secondary
Safety of Chemo-radiotherapy
A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
Time frame: Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy
Population: All enrolled participants receiving chemo-radiotherapy (Cycle 4).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Radiation Esophagitis - Grade 4 | 0 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Neutropenia - Grade 3 | 6 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Neutropenia - Grade 4 | 2 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Thrombocytopenia - Grade 3 | 7 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Thrombocytopenia - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Radiation Esophagitis - Grade 3 | 4 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Radiation Pneumonitis - Grade 3 | 1 participants |
| Gemcitabine + Cisplatin | Safety of Chemo-radiotherapy | Radiation Pneumonitis - Grade 4 | 0 participants |
Secondary
Safety of Induction Chemotherapy
A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening.
Time frame: every cycle (21 days) for 3 cycles (up to 10 weeks)
Population: All enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Safety of Induction Chemotherapy | Neutropenia - Grade 4 | 8 participants |
| Gemcitabine + Cisplatin | Safety of Induction Chemotherapy | Thrombocytopenia - Grade 3 | 4 participants |
| Gemcitabine + Cisplatin | Safety of Induction Chemotherapy | Thrombocytopenia - Grade 4 | 1 participants |
| Gemcitabine + Cisplatin | Safety of Induction Chemotherapy | Neutropenia - Grade 3 | 9 participants |
Secondary
Time to Progressive Disease
Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included.
Time frame: Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years);
Population: All enrolled participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gemcitabine + Cisplatin | Time to Progressive Disease | Preliminary | 10.9 months |
| Gemcitabine + Cisplatin | Time to Progressive Disease | Final | 11.4 months |