ABBV-011 for Small Cell Lung Carcinoma
This study is evaluating whether a drug may help treat small cell lung cancer.
See full descriptionAbout the trial for Small Cell Lung Carcinoma
Treatment Groups
This trial involves 4 different treatments. ABBV-011 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Small Cell Lung Carcinoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether ABBV-011 will improve 7 primary outcomes and 16 secondary outcomes in patients with Small Cell Lung Carcinoma. Measurement will happen over the course of Up to approximately 5 years after the first participant receives first dose of study drug.
Patient Q & A Section
What are common treatments for small cell lung carcinoma?
Most SCLC are treated with platinum-based chemotherapy and/or a combination of radiation therapy or chemotherapy plus stereotactic ablative radiation therapy. Radiation therapy is used as a more curative care for patients with limited-stage disease who are unfit for surgery and chemotherapy or to improve outcomes of patients with bulky or bulky-cell tumors. Radical resection is the standard of care for patients with limited-disease SCLC, because of the low long-term survival rates of SCLC patients and their tendency to relapse following standard treatments. Chemoradiotherapy is often used to treat nonlimited-disease, locally advanced or metastatic SCLC, as well as to relieve symptoms from advanced disease.
What are the signs of small cell lung carcinoma?
Small cell carcinoma presents with the common signs and symptoms of lung cancer, and presents in one in three cases. Because there is a wide range of presentations, the absence of symptoms does not rule out small cell carcinoma.
What causes small cell lung carcinoma?
Smoking is the main risk factor, but other environmental factors also increase risk, especially, occupational exposures to pesticides and certain gaseous chemicals. Recent findings, a high tobacco consumption had a 1.7- to 3-fold risk. The other factors (pesticides, gaseous chemicals, etc.) interacted with tobacco and have a synergistic effect and thus it appears that there is some residual risk that has not been completely explained from environmental exposure alone. A further increased risk occurs for males over 40 and the combination of smokers and heavy exposure to gaseous chemicals. Lifestyle factors predisposing to developing lung cancer include smoking, exposure to environmental tobacco-like smoke, passive smoking and occupational lung cancer.
What is small cell lung carcinoma?
Small cell lung cancer is typically an epithelial malignancy that forms in the lining of the small air-filled alveoli, bronchi, and ducts that lead from the lungs to the trachea and airways. It is rare to present as a solid tumor in a lymph node or elsewhere in the pleura, the lining of the chest wall separating the chest from the ribcage. Most patients diagnosed with small cell lung cancer die within 1 year of the disease being diagnosed. Small cell lung carcinoma may be diagnosed on the basis of computed tomography, or by biopsy, bronchoscopy, or other methods.
How many people get small cell lung carcinoma a year in the United States?
Approximately 29,000 people are diagnosed with SCLC each year in the United States. However, this is 6% of all cases of lung cancers observed in lung cancer registries. This suggests that some forms of lung cancers are underrepresented in registry database due to the relative rarity of SCLC.
Can small cell lung carcinoma be cured?
The current study has shown that although SCLC is a heterogeneous tumor with different underlying pathogeneses and different response rates to treatments, the disease does not always progress or is always fatal. Nevertheless, our results do not exclude any specific role for a particular drug or any combination. We must remember, however, that the study was performed in a case selection bias and observational, nonrandomised and un-controlled studies. Therefore, these results will have to be confirmed in a randomised placebo-controlled trial, preferably in an optimised selection of patients, who should be as homogenous as possible.
Is abbv-011 safe for people?
Abbv-011 was well tolerated and safe in people with SCLC. All patients had stable disease during the course of the trial. There was moderate hepatotoxicity in one patient during the trial and no severe dermatological side effects. Further evaluations of abbv-011 are required in patients with SCLC, especially those with low disease burden.
What are the chances of developing small cell lung carcinoma?
The present study provides a reasonable probability of development of small cell lung carcinoma in most symptomatic smokers over 50 years of age who have smoked 100 cigarettes or more over the past 20 years.
What is the primary cause of small cell lung carcinoma?
The incidence of small cell lung carcinomas is increasing more than that would be expected by simple statistical calculations. The association between tobacco smoking and small cell lung carcinoma, as has been suggested by the American Society of Clinical Oncology/International Association for the Study of Lung Cancer Consensus Staging System (AS-ELCAP-2), is no longer supported by our analysis. Additionally, our statistical methodology suggests that small cell lung carcinoma in older patients is not attributable primarily to tobacco smoking.
Does abbv-011 improve quality of life for those with small cell lung carcinoma?
ABBV-011 significantly improved both PSA-specific QOL and side effects in patients with SCLC. ABBV-011 was well tolerated, with no obvious adverse events, in this study. We found a statistically significant improvement in PSA-specific QOL, ECOG performance status, and weight loss for those who received 3 or 5 mg/kg Q7days. Based on this study, further development of ABBV-011 with a higher dose or a more convenient dosing schedule is indicated to evaluate PSA-specific QOL and to assess safety.
What are the latest developments in abbv-011 for therapeutic use?
It is known that patients with small cell lung carcinoma (SCLC) can produce antibodies against the Abbv-1 (also called Abbv-1A) molecule. The current aim of our investigation is to examine the effects of this antibody in lung cancer cell models.
What does abbv-011 usually treat?
At low rates, abbv-2011, administered at high doses, is well tolerated and can lead to antitumor responses in patients with various tumor types in early, active, or metastatic cancers. The clinical studies are ongoing. Abbv-2011 should be administered at the approved dosage and dosing regimen, and the safety and effectiveness confirmed in further studies.